Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Terminated
CT.gov ID
NCT02846740
Collaborator
(none)
30
1
2
10.7
2.8

Study Details

Study Description

Brief Summary

This pilot study aims to investigate whether a treatment called cranial electric stimulation or CES can decrease risk factors for suicide. The specific CES device we will use is called Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).

Condition or Disease Intervention/Treatment Phase
  • Device: Alpha-Stim®.
  • Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
N/A

Detailed Description

Suicide is still a major issue in the United States and all around the world. There are many reasons for people attempting suicide and the major modifiable risk factors are depression, anxiety, insomnia, and agitation. The standard treatment for all suicidal patients includes medication, admission to a hospital and reducing the risk factors. Medications have potential side effects and concerns about the drug interactions. One of the biological treatment alternatives to medication is cranial electric stimulation. This technique uses a device to stimulate the brain through electrical current. Using an Alpha-Stim® device, current is applied to the brain using skin electrodes which can be easily clipped on to the earlobe. The amount of current used is very low and is 1/1000 th of the current used for electroconvulsive therapy (ECT) and 1/10 th to 1/20 th of the 1-2 milliamperes used with transcranial direct current stimulation (tDCS). Our goal is to examine the safety and efficacy of this device when used as an add-on or adjunctive treatment to the usual treatments during the inpatient stay.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jan 22, 2018
Actual Study Completion Date :
Jan 22, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Adjunctive CES

CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.

Device: Alpha-Stim®.
cranial electrical stimulation

Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).

Sham Comparator: Sham control CES

For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.

Device: Alpha-Stim®.
cranial electrical stimulation

Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).

Outcome Measures

Primary Outcome Measures

  1. Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score [Baseline, 22 months,]

    Efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors (MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include Montgomery-Åsberg Depression Rating Scale (range very severe = 44; severe = 31; moderate = 25; mild = 15; & recovered = 7), Hamilton Anxiety Rating Scale (range of 0-56, <17 indicates mild severity, 18-24, moderate severity & 25-30 severe). Both scales were summed, the full theoretical scale range is 0-116, with higher scores indicating a worse outcome. Due to short hospital stays, we were not able to use Agitated Behavior Scale and Pittsburgh Sleep Quality Index scale in a meaningful manner to include in our analysis, so we did not include that scale.

  2. Adverse Effects and Safety [Baseline, 22 months,]

    Safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary safety outcome measure will be responses to an adverse effect assessment questionnaire (GASE questionnaire).

Secondary Outcome Measures

  1. Length of Stay [Baseline, 22 months,]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Subject must be a patient admitted voluntarily to the UMMC adult psychiatric inpatient services with suicidal thoughts / intent / plan or suicide attempt who also has MSRFs including anxiety, agitation, insomnia, and/or depression).

  2. Subject must be between the ages of 18 and 65 (inclusive). Both men and women will be included

  3. Subjects who are female must have a negative pregnancy test prior to enrolling in the study, and must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, or oral/hormonal contraception or abstinence, which is typically the case on the inpatient units.

  4. If a subject has a substance abuse disorder, they must also have another non-substance abuse psychiatric disorder as determined from the clinical history.

  5. Chronic medical conditions such as endocrine disease, hypertension, renal disease, must be stable.

  6. Subject must be capable of giving informed consent. Subject must provide written informed consent prior to study participation.

  7. Subject must be capable of doing active or sham CES treatments and completing all study requirements.

Exclusion Criteria:
  1. Subject has a significant medical disorder with acute symptoms which could impair reliable participation in the trial or affect their MSRFs.

  2. Subject is pregnant.

  3. Subject has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.

  4. Subject has a clinical history of poor compliance or in the investigator's judgment participation in the study would be clinically contraindicated.

  5. Subject has current or past behavior that suggests to the investigator that his/her suicidal behavior is driven by secondary gain, i.e. expressing suicidal thoughts so that s/he can be admitted due to homelessness.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Maryland School of Medicine Baltimore Maryland United States 21201

Sponsors and Collaborators

  • University of Maryland, Baltimore

Investigators

  • Principal Investigator: Nithin E Krishna, MD, University of Maryland, Baltimore

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Nithin Krishna, Assistant Professor of Psychiatry, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT02846740
Other Study ID Numbers:
  • HP-00065640
First Posted:
Jul 27, 2016
Last Update Posted:
Dec 26, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Nithin Krishna, Assistant Professor of Psychiatry, University of Maryland, Baltimore
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Adjunctive CES Sham Control CES
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Period Title: Overall Study
STARTED 15 15
COMPLETED 15 14
NOT COMPLETED 0 1

Baseline Characteristics

Arm/Group Title Adjunctive CES Sham Control CES Total
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). Total of all reporting groups
Overall Participants 15 15 30
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
15
100%
15
100%
30
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
33.87
(2)
31.87
(2.5)
32.87
(1.8)
Sex: Female, Male (Count of Participants)
Female
7
46.7%
6
40%
13
43.3%
Male
8
53.3%
9
60%
17
56.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
Asian
1
6.7%
3
20%
4
13.3%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
7
46.7%
6
40%
13
43.3%
White
7
46.7%
6
40%
13
43.3%
More than one race
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
15
100%
15
100%
30
100%

Outcome Measures

1. Primary Outcome
Title Change From Baseline in the Modifiable Suicide Risk Factors (MSRF's) Global Score
Description Efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors (MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include Montgomery-Åsberg Depression Rating Scale (range very severe = 44; severe = 31; moderate = 25; mild = 15; & recovered = 7), Hamilton Anxiety Rating Scale (range of 0-56, <17 indicates mild severity, 18-24, moderate severity & 25-30 severe). Both scales were summed, the full theoretical scale range is 0-116, with higher scores indicating a worse outcome. Due to short hospital stays, we were not able to use Agitated Behavior Scale and Pittsburgh Sleep Quality Index scale in a meaningful manner to include in our analysis, so we did not include that scale.
Time Frame Baseline, 22 months,

Outcome Measure Data

Analysis Population Description
Many patients were discharged within a few days of admission, some left in two days, which left us with just baseline and several missing scales.
Arm/Group Title Adjunctive CES Sham Control CES
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Measure Participants 15 15
Mean (Standard Deviation) [score on a scale]
35.33
(1.02)
36.5
(1.04)
2. Primary Outcome
Title Adverse Effects and Safety
Description Safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary safety outcome measure will be responses to an adverse effect assessment questionnaire (GASE questionnaire).
Time Frame Baseline, 22 months,

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Adjunctive CES Sham Control CES
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Measure Participants 15 15
Count of Participants [Participants]
0
0%
0
0%
3. Secondary Outcome
Title Length of Stay
Description
Time Frame Baseline, 22 months,

Outcome Measure Data

Analysis Population Description
This was a difficult analysis considering patients had different motives for staying versus discharge
Arm/Group Title Adjunctive CES Sham Control CES
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
Measure Participants 15 15
Mean (Standard Deviation) [Days]
11
(0.5)
12
(0.8)

Adverse Events

Time Frame Adverse events were collected throughout the study, up to 22 months.
Adverse Event Reporting Description There were no reports of any serious adverse events or side effects from due to the study.
Arm/Group Title Adjunctive CES Sham Control CES
Arm/Group Description CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's). For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device. Alpha-Stim®.: cranial electrical stimulation Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale: A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
All Cause Mortality
Adjunctive CES Sham Control CES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (0%)
Serious Adverse Events
Adjunctive CES Sham Control CES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Adjunctive CES Sham Control CES
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (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.

Results Point of Contact

Name/Title Nithin krishna
Organization University of Maryland Baltimore
Phone 4103286661
Email nkrishna@som.umaryland.edu
Responsible Party:
Nithin Krishna, Assistant Professor of Psychiatry, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT02846740
Other Study ID Numbers:
  • HP-00065640
First Posted:
Jul 27, 2016
Last Update Posted:
Dec 26, 2019
Last Verified:
Dec 1, 2019