HIRREM Developmental Study
Study Details
Study Description
Brief Summary
The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active HIRREM This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
Device: HIRREM
HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.
|
Outcome Measures
Primary Outcome Measures
- Heart Rate Variability Standard Deviation of NN Intervals (SDNN) [Baseline/Enrollment visit]
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
- Heart Rate Variability (SDNN) [Up to 2 weeks after the intervention is completed]
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
- Baroreflex Sensitivity High Frequency (HF) Alpha [Baseline/Enrollment visit]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity High Frequency (HF) Alpha [Up to two weeks after the intervention is completed]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Up [Baseline/Enrollment visit]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Up [Up to two weeks after the intervention is completed]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Down [Baseline/Enrollment visit]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Down [Up to two weeks after the intervention is completed]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence All [Baseline/Enrollment visit]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence All [Up to 2 weeks after the intervention is completed]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Secondary Outcome Measures
- Center for Epidemiologic Studies Depression Scale (CES-D) [enrollment visit/baseline]
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
- Center for Epidemiologic Studies Depression Scale (CES-D) [1-2 weeks after intervention is completed]
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
- Center for Epidemiologic Studies Depression Scale (CES-D) [4-8 weeks after completion of the intervention]
The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology.
- Euro Quality of Life--Five Dimension (EQ-5D) [enrollment visit/baseline]
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
- Euro Quality of Life--Five Dimension (EQ-5D) [1-2 weeks after the intervention is completed]
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
- Euro Quality of Life--Five Dimension (EQ-5D) [4-8 weeks after completion of the intervention]
The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome.
- Generalized Anxiety Disorder-7 (GAD-7) [enrollment visit/baseline]
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
- Generalized Anxiety Disorder-7 (GAD-7) [1-2 weeks after the intervention is completed]
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
- Generalized Anxiety Disorder-7 (GAD-7) [4-8 weeks after completion of the intervention]
The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety.
- Insomnia Severity Index (ISI) [enrollment visit/baseline]
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
- Insomnia Severity Index (ISI) [1-2 weeks after the intervention is completed]
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
- Insomnia Severity Index (ISI) [4-8 weeks after completion of the intervention]
The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality.
- Posttraumatic Stress Disorder Checklist (PCL-C) [enrollment visit/baseline]
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
- Posttraumatic Stress Disorder Checklist (PCL) [1-2 weeks after the intervention is completed]
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
- Posttraumatic Stress Disorder Checklist (PCL) [4-8 weeks after completion of the intervention]
The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD.
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [enrollment visit/baseline]
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [1-2 weeks after the intervention is completed]
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity.
- Rivermead Post-Concussion Symptoms Questionnaire (RPQ) [4-8 weeks after completion of the intervention]
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity.
- Drop Stick Reaction Testing [enrollment visit/baseline]
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
- Drop Stick Reaction Testing [1-2 weeks after the intervention is completed]
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
- Drop Stick Reaction Testing [4-8 weeks after completion of the intervention]
Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100.
Other Outcome Measures
- Heart Rate Variability Standard Deviation of NN Intervals (SDNN) [4-8 weeks after completion of the intervention]
Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval
- Baroreflex Sensitivity High Frequency (HF) Alpha [4-8 weeks after completion of the intervention]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Up [4-8 weeks after completion of the intervention]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence Down [4-8 weeks after completion of the intervention]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
- Baroreflex Sensitivity Sequence All [4-8 weeks after completion of the intervention]
Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male and female adults and children aged 11 years and older.
-
Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
-
Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
-
Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.
Exclusion Criteria:
-
Subjects who fail to meet inclusion criteria.
-
Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
-
Subjects physically unable to come to the study visits.
-
Subjects with a known seizure disorder.
-
Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
-
Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
-
Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Neurology, Wake Forest School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Charles H Tegeler, MD, Wake Forest University Health Sciences
Study Documents (Full-Text)
More Information
Publications
- Gerdes L, Gerdes P, Lee SW, H Tegeler C. HIRREM™: a noninvasive, allostatic methodology for relaxation and auto-calibration of neural oscillations. Brain Behav. 2013 Mar;3(2):193-205. doi: 10.1002/brb3.116. Epub 2013 Jan 14.
- Gerdes L, Tegeler CH, Lee SW. A groundwork for allostatic neuro-education. Front Psychol. 2015 Aug 17;6:1224. doi: 10.3389/fpsyg.2015.01224. eCollection 2015.
- Tegeler CH, Kumar SR, Conklin D, Lee SW, Gerdes L, Turner DP, Tegeler CL, C Fidali B, Houle TT. Open label, randomized, crossover pilot trial of high-resolution, relational, resonance-based, electroencephalic mirroring to relieve insomnia. Brain Behav. 2012 Nov;2(6):814-24. doi: 10.1002/brb3.101. Epub 2012 Oct 28.
- Tegeler CH, Lee SW, Shaltout HA. Significance of right anterior insula activity for mental health intervention. JAMA Psychiatry. 2014 Mar;71(3):336. doi: 10.1001/jamapsychiatry.2013.3507.
- IRB00017651
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Period Title: Overall Study | |
| STARTED | 300 |
| COMPLETED | 273 |
| NOT COMPLETED | 27 |
Baseline Characteristics
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Overall Participants | 300 |
| Age (Count of Participants) | |
| <=18 years |
30
10%
|
| Between 18 and 65 years |
228
76%
|
| >=65 years |
42
14%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
166
55.3%
|
| Male |
134
44.7%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| African American |
15
5%
|
| Asian |
5
1.7%
|
| Hispanic or Latino |
3
1%
|
| White |
276
92%
|
| Other |
1
0.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
300
100%
|
Outcome Measures
| Title | Heart Rate Variability Standard Deviation of NN Intervals (SDNN) |
|---|---|
| Description | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval |
| Time Frame | Baseline/Enrollment visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [milliseconds] |
44.41
(22.94)
|
| Title | Heart Rate Variability (SDNN) |
|---|---|
| Description | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval |
| Time Frame | Up to 2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [milliseconds] |
54.82
(30.63)
|
| Title | Baroreflex Sensitivity High Frequency (HF) Alpha |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Baseline/Enrollment visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms^2] |
18.81
(14.45)
|
| Title | Baroreflex Sensitivity High Frequency (HF) Alpha |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Up to two weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms^2] |
26.68
(20.69)
|
| Title | Baroreflex Sensitivity Sequence Up |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Baseline/Enrollment visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 226 |
| Mean (Standard Deviation) [ms/mmHg] |
15.39
(13.88)
|
| Title | Baroreflex Sensitivity Sequence Up |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Up to two weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 226 |
| Mean (Standard Deviation) [ms/mmHg] |
14.15
(11.56)
|
| Title | Baroreflex Sensitivity Sequence Down |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Baseline/Enrollment visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms/mmHg] |
14.15
(11.56)
|
| Title | Baroreflex Sensitivity Sequence Down |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Up to two weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms/mmHg] |
20.73
(16.76)
|
| Title | Baroreflex Sensitivity Sequence All |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Baseline/Enrollment visit |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms/mmHg] |
14.63
(11.80)
|
| Title | Baroreflex Sensitivity Sequence All |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | Up to 2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| BIOPAC device was acquired prior to subject 38. Other entries were excluded due to missing or dropped heartbeats. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 227 |
| Mean (Standard Deviation) [ms/mmHg] |
20.74
(16.30)
|
| Title | Center for Epidemiologic Studies Depression Scale (CES-D) |
|---|---|
| Description | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 233 |
| Mean (Standard Deviation) [score on a scale] |
18.12
(12.16)
|
| Title | Center for Epidemiologic Studies Depression Scale (CES-D) |
|---|---|
| Description | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. |
| Time Frame | 1-2 weeks after intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 233 |
| Mean (Standard Deviation) [score on a scale] |
10.00
(8.96)
|
| Title | Center for Epidemiologic Studies Depression Scale (CES-D) |
|---|---|
| Description | The CES-D is a 20-item survey assessing affective depressive symptomatology to screen for risk of depression. Scores range from 0-60, with a score of 16 commonly used as a clinically relevant cut-off. Higher scores suggest the presence of more symptomatology. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| CES-D was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 115 |
| Mean (Standard Deviation) [score on a scale] |
8.91
(8.28)
|
| Title | Euro Quality of Life--Five Dimension (EQ-5D) |
|---|---|
| Description | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 202 |
| Mean (Standard Deviation) [score on a scale] |
69.55
(19.69)
|
| Title | Euro Quality of Life--Five Dimension (EQ-5D) |
|---|---|
| Description | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 202 |
| Mean (Standard Deviation) [score on a scale] |
79.12
(16.42)
|
| Title | Euro Quality of Life--Five Dimension (EQ-5D) |
|---|---|
| Description | The EQ-5D is a brief, standardized measure of health status developed by the EuroQol Group, and is a paper and pencil survey providing a single index value for health status. The score reported is current health status which ranges from 0 to 100 with a higher score denoting a better outcome. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| EQ-5D was added as a study measure at subject 79. Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 151 |
| Mean (Standard Deviation) [score on a scale] |
78.36
(17.84)
|
| Title | Generalized Anxiety Disorder-7 (GAD-7) |
|---|---|
| Description | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 167 |
| Mean (Standard Deviation) [score on a scale] |
8.31
(6.01)
|
| Title | Generalized Anxiety Disorder-7 (GAD-7) |
|---|---|
| Description | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 167 |
| Mean (Standard Deviation) [score on a scale] |
4.35
(4.19)
|
| Title | Generalized Anxiety Disorder-7 (GAD-7) |
|---|---|
| Description | The Generalized Anxiety Disorder-7 (GAD-7) is a seven item screening tool for anxiety that is widely used in primary care. Scores range from 0 to 21 with higher scores suggesting anxiety. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| GAD-7 was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 133 |
| Mean (Standard Deviation) [score on a scale] |
3.66
(3.49)
|
| Title | Insomnia Severity Index (ISI) |
|---|---|
| Description | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 272 |
| Mean (Standard Deviation) [score on a scale] |
13.47
(7.17)
|
| Title | Insomnia Severity Index (ISI) |
|---|---|
| Description | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 270 |
| Mean (Standard Deviation) [score on a scale] |
7.09
(5.90)
|
| Title | Insomnia Severity Index (ISI) |
|---|---|
| Description | The ISI measures the severity of insomnia symptoms. The ISI is a 7 question measure, with responses from 0-4 for each question, yielding scores ranging from 0-28 where lower scores denote a healthier sleep quality. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 160 |
| Mean (Standard Deviation) [score on a scale] |
6.22
(5.43)
|
| Title | Posttraumatic Stress Disorder Checklist (PCL-C) |
|---|---|
| Description | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 179 |
| Mean (Standard Deviation) [score on a scale] |
38.75
(15.43)
|
| Title | Posttraumatic Stress Disorder Checklist (PCL) |
|---|---|
| Description | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 179 |
| Mean (Standard Deviation) [score on a scale] |
28.50
(11.37)
|
| Title | Posttraumatic Stress Disorder Checklist (PCL) |
|---|---|
| Description | The PCL - Civilian (C) is a symptom checklist to measure stress severity due to a traumatic experience, in civilian settings. Seventeen items are rated on a Likert scale with a composite score range of 17 to 85. A score of 44 or higher correlates with probability of civilian-related PTSD. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported trauma or PTSD on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 91 |
| Mean (Standard Deviation) [score on a scale] |
26.13
(9.58)
|
| Title | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) |
|---|---|
| Description | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 48 |
| Mean (Standard Deviation) [score on a scale] |
29.60
(12.82)
|
| Title | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) |
|---|---|
| Description | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with a higher score denoting the greatest symptom severity. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 48 |
| Mean (Standard Deviation) [score on a scale] |
15.79
(13.96)
|
| Title | Rivermead Post-Concussion Symptoms Questionnaire (RPQ) |
|---|---|
| Description | The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) is a 16-item survey that assesses the severity of the most common post-concussion symptoms on a scale of 0 to 4, with a total score range from 0 to 64 with 64 denoting the greatest symptom severity. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Entries were excluded if there was incomplete or missing data. Scale was exploratory and only administered to people who self-reported TBI or concussion on medical history form. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 35 |
| Mean (Standard Deviation) [score on a scale] |
16.89
(14.74)
|
| Title | Drop Stick Reaction Testing |
|---|---|
| Description | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. |
| Time Frame | enrollment visit/baseline |
Outcome Measure Data
| Analysis Population Description |
|---|
| Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 213 |
| Mean (Standard Deviation) [cm] |
27.20
(8.25)
|
| Title | Drop Stick Reaction Testing |
|---|---|
| Description | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. |
| Time Frame | 1-2 weeks after the intervention is completed |
Outcome Measure Data
| Analysis Population Description |
|---|
| Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 213 |
| Mean (Standard Deviation) [cm] |
23.40
(6.78)
|
| Title | Drop Stick Reaction Testing |
|---|---|
| Description | Reaction testing is measured by a drop-stick apparatus that has been validated as a way to quantify the impact of athletic concussion on psychomotor performance. Following two practice trials, participants perform eight trials, and a mean distance value is calculated. Better reaction time is denoted by a lower score. The scores range from 0 to 100. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| Drop stick reaction testing was temporarily removed as approved measure of depression (35 subjects). Other entries were excluded if there was incomplete or missing data. Late data collection visit was added at after participant 65. Out of town subjects typically were not able to make it back for late data collections. |
| Arm/Group Title | Active HIRREM |
|---|---|
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. |
| Measure Participants | 90 |
| Mean (Standard Deviation) [cm] |
22.58
(5.78)
|
| Title | Heart Rate Variability Standard Deviation of NN Intervals (SDNN) |
|---|---|
| Description | Heart rate variability is measured in the time domain as standard deviation of beat-to-beat interval |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Baroreflex Sensitivity High Frequency (HF) Alpha |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Baroreflex Sensitivity Sequence Up |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Baroreflex Sensitivity Sequence Down |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Baroreflex Sensitivity Sequence All |
|---|---|
| Description | Analysis is conducted on the first complete 5-minute epoch that is considered to be acceptable for analysis using Nevrokard Baroreflex Sensitivity (BRS) software. |
| Time Frame | 4-8 weeks after completion of the intervention |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | Informed consent until 4-8 weeks after completion of the intervention | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Active HIRREM | |
| Arm/Group Description | This is a single site, single-arm, open-label, developmental study. Participants are recruited to receive eight to twenty sessions of High-resolution, relational, resonance-based electroencephalic mirroring (HIRREM), in addition to their usual care. | |
All Cause Mortality |
||
| Active HIRREM | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Serious Adverse Events |
||
| Active HIRREM | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Active HIRREM | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/300 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Charles H. Tegeler |
|---|---|
| Organization | Wake Forest School of Medicine |
| Phone | +1 (336) 716-7651 |
| ctegeler@wakehealth.edu |
- IRB00017651