Neurofeedback-enhanced Mindfulness Meditation in Traumatic Brain Injury

• Sponsor: Spaulding Rehabilitation Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02615535
• Collaborator: InteraXon, Inc. (Industry)
• Enrollment: 25
• Location: 1
• Arms: 2
• Actual Duration (Months): 48
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Spaulding Rehabilitation Hospital is conducting a research study evaluating the effectiveness of the brain-training product, MUSE, an EEG-guided neurofeedback device designed to assist in cultivating a relaxed, attentive state of mind during meditation. The investigators study aims to evaluate whether such a tool could be useful in treating persistent traumatic brain injury symptoms such as inattention, impulsivity, irritability, or dysregulated mood.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury	Device: EEG neurofeedback-assisted meditation; Device: Non-EEG feedback-assisted meditation	N/A

Detailed Description

Twenty subjects in total will participate in this study. Subjects will be randomized to focused-attention meditation training with or without the neurofeedback device, MUSE. Subjects will be asked to practice ~10 min of daily meditation for 6-8 weeks. Neuropsychological testing will be performed at the beginning of the study and after six weeks of training. At this time point, those randomized to the non-MUSE group will be given a device and asked to train for an additional two weeks. At the conclusion of the study, all subjects will also undergo a brief telephone or in-person exit interview regarding their experiences using the MUSE device.

Primary endpoint: change in Neurobehavioral Symptom Inventory

Secondary endpoints: change in the following: Wechsler Adult Intelligence Scale-IV Digit Span and Symbol-Digit Coding, Trail-Making Test, Beck Anxiety Inventory, Beck Depression Inventory, Cognitive and Affective Mindfulness Scale-Revised, percentage of EEG activity associated with alpha, beta, or theta activity.

Study Design

• Study Type: Interventional
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Neurofeedback-enhanced Mindfulness Meditation for the Treatment of Affective and Attentional Disturbances in Patients With Traumatic Brain Injury
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EEG neurofeedback-assisted meditation EEG neurofeedback assisted meditation using the MUSE device and auditory feedback.	Device: EEG neurofeedback-assisted meditation; meditation with auditory feedback regarding EEG status; Other Names: MUSE
Active Comparator: Non-EEG feedback-assisted meditation Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback.	Device: Non-EEG feedback-assisted meditation; meditation without auditory feedback regarding EEG status; Other Names: MUSE without EEG feedback

Outcome Measures

Primary Outcome Measures

1. Change in Neurobehavioral Symptom Inventory [baseline and six weeks]

   Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.

Secondary Outcome Measures

1. Change in Wechsler Adult Intelligence Scale-IV Digit Span [baseline and six weeks]

   Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.

2. Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding [baseline and six weeks]

   A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome.

3. Change in Trail Making Test [baseline and six weeks]

   Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome.

4. Change in Beck Anxiety Inventory [baseline and six weeks]

   Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.

5. Change in Beck Depression Inventory-II [baseline and six weeks]

   Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome.

6. Change in Cognitive and Affective Mindfulness Scale-Revised [baseline and six weeks]

   Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome.

7. Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device [baseline and at six weeks]

   Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. history of mild-moderate traumatic brain injury

2. impaired attention or concentration

3. 1 year since traumatic brain injury

4. ability to participate in neurofeedback and mindfulness meditation

5. daily access to a smart phone

6. on stable dosage of neuropsychological medications with no significant changes planned for the duration of the study

7. no prior history of a meditation practice

Exclusion Criteria:

1. severe mental illness or psychological symptoms (severe depression, suicidality, disabling anxiety, PTSD, psychosis, dissociation)

2. significant pre-morbid learning disability

3. current or recent (in past year) history of significant drug or alcohol abuse

4. medical illness severe enough to result in an attentional disorder

5. neurodegenerative disease

6. non-fluency in English.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spaulding Rehabilitation Hospital Boston	Charlestown	Massachusetts	United States	02129

Sponsors and Collaborators

• Spaulding Rehabilitation Hospital
• InteraXon, Inc.

Investigators

• Principal Investigator: Mel B Glenn, MD, Spaulding Rehabilitation Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 1, 2016

More Information

Publications

• Brandmeyer T, Delorme A. Meditation and neurofeedback. Front Psychol. 2013 Oct 7;4:688. doi: 10.3389/fpsyg.2013.00688. eCollection 2013.
• Chiesa A, Calati R, Serretti A. Does mindfulness training improve cognitive abilities? A systematic review of neuropsychological findings. Clin Psychol Rev. 2011 Apr;31(3):449-64. doi: 10.1016/j.cpr.2010.11.003. Epub 2010 Dec 1. Review.
• Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015. Review.
• Hofmann SG, Sawyer AT, Witt AA, Oh D. The effect of mindfulness-based therapy on anxiety and depression: A meta-analytic review. J Consult Clin Psychol. 2010 Apr;78(2):169-83. doi: 10.1037/a0018555.

• Responsible Party: Mel B. Glenn, Director of Outpatient and Community Brain Injury Rehabilitation, Spaulding Rehabilitation Hospital
• ClinicalTrials.gov Identifier: NCT02615535
• Other Study ID Numbers: 2015P002184
• First Posted: Nov 26, 2015
• Last Update Posted: Mar 30, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Mel B. Glenn, Director of Outpatient and Community Brain Injury Rehabilitation, Spaulding Rehabilitation Hospital: traumatic brain injury
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Alprostadil

Study Results

Participant Flow

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Period Title: Overall Study
STARTED	14	11
COMPLETED	10	10
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation	Total
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.3 (3.6)	41.4 (4.7)	45.4 (3)
Sex: Female, Male (Count of Participants)
Female	9 90%	8 80%	17 85%
Male	1 10%	2 20%	3 15%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 10%	1 5%
Not Hispanic or Latino	10 100%	9 90%	19 95%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Change in Neurobehavioral Symptom Inventory
Description	Measures common symptoms after head injury. This scales ranges from 0-4 on 22 items, for a minimum score of 0 and a maximum score of 88. Higher scores mean a greater severity of symptoms.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	35.2 (3)	33.1 (5.1)
6 weeks	27.7 (2.8)	24.6 (3.9)

2. Secondary Outcome

Title	Change in Wechsler Adult Intelligence Scale-IV Digit Span
Description	Tests participants digit span, repeating forward sequences of digits from 2 to 8. Scale ranges from 0 to 16. Higher scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	10.4 (0.7)	11.2 (1)
six weeks	10.9 (0.6)	11.8 (0.8)

3. Secondary Outcome

Title	Change in Wechsler Adult Intelligence Scale-IV Digit Symbol Coding
Description	A subject is provided with a key matching nine numbers to nine unique symbols. Numbers are then provided in random order and subjects have 120 seconds to match as many numbers with symbols as possible. All correct responses are scored. Scores range from 0 to 135. Scores are later scaled from 1 to 19. Higher scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	11.6 (1.2)	11.1 (0.9)
six weeks	13.1 (1.1)	12.5 (0.8)

4. Secondary Outcome

Title	Change in Trail Making Test
Description	Subjects are asked to sequence numbers and letters represented on a page as quickly as then can. Results are measured in seconds, ranging from 0 (hypothetically) to an infinite number (hypothetically). Results are scaled from 1 to 19. Lower scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	10.9 (1)	11.9 (0.4)
six weeks	12.3 (0.8)	12.7 (0.4)

5. Secondary Outcome

Title	Change in Beck Anxiety Inventory
Description	Subjects rate on a 0-3 likert scales responses to questions about anxiety. Scores range from 0-63. Lower scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	15.9 (1.9)	18.8 (4.6)
six weeks	11.5 (1.9)	8.5 (1.8)

6. Secondary Outcome

Title	Change in Beck Depression Inventory-II
Description	Subjects respond to questions on a Likert scale from 0-3 regarding depressive symptoms. There are 21 items. Scores range from 0-63. Lower scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	19.9 (3.6)	17 (3.5)
six weeks	13.1 (3.1)	9.9 (2.8)

7. Secondary Outcome

Title	Change in Cognitive and Affective Mindfulness Scale-Revised
Description	Subjects answer questions regarding mindfulness on a Likert Scale from 1-4. There are twelve questions total. Scores range from 4-48. Higher scores mean a better outcome.
Time Frame	baseline and six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	24.2 (2)	24.7 (1.8)
six weeks	27.3 (1.6)	28.3 (2.1)

8. Secondary Outcome

Title	Change in Percentage of EEG Activity Associated With Alpha, Beta, and Theta Rhythms as Measured by Surface Electrodes on the MUSE Device
Description	Change in "percent Calm" as determined by Muse device. Equations behind this algorithm to determine "Calm" are proprietary and were not shared by the device manufacturer. Ranges from 0% to 100%. Higher scores mean a better outcome.
Time Frame	baseline and at six weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EEG Neurofeedback-assisted Meditation	Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status	Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
Measure Participants	10	10
baseline	49.7 (5.6)	32 (7.8)
six weeks	57.7 (7.6)	43.7 (9.9)

Adverse Events

Time Frame	Adverse effects from meditation were not anticipated. Subjects practiced meditation for six weeks each. If adverse effects occurred during the six weeks, they contacted our group. At our post-intervention assessment at six weeks, we asked specifically about adverse events. Adverse events were not monitored beyond the intervention period of six weeks.
Adverse Event Reporting Description	Definitions are consistent.
Arm/Group Title	EEG Neurofeedback-assisted Meditation		Non-EEG Feedback-assisted Meditation
Arm/Group Description	EEG neurofeedback assisted meditation using the MUSE device and auditory feedback. EEG neurofeedback-assisted meditation: meditation with auditory feedback regarding EEG status		Non-EEG neurofeedback assisted meditation. Subjects will have auditory instruction from the MUSE device without the EEG neurofeedback. Non-EEG feedback-assisted meditation: meditation without auditory feedback regarding EEG status
All Cause Mortality
	EEG Neurofeedback-assisted Meditation		Non-EEG Feedback-assisted Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	EEG Neurofeedback-assisted Meditation		Non-EEG Feedback-assisted Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	EEG Neurofeedback-assisted Meditation		Non-EEG Feedback-assisted Meditation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.