Brain Stimulation and Cognitive Training

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT03338673
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

People with serious mental illness often report difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits.

This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises.

Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.

Condition or Disease	Intervention/Treatment	Phase
Bipolar Disorder; Schizo Affective Disorder; Schizophrenia	Device: tDCS; Other: BrainHQ	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other conditionParticipants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
• Actual Study Start Date: Oct 11, 2018
• Actual Primary Completion Date: Sep 27, 2019
• Actual Study Completion Date: Sep 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual Therapy First Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone	Device: tDCS; tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function; Other Names: Transcranial direct current stimulation ; Other: BrainHQ; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory; Other Names: Computerized cognitive exercises
Experimental: Mono Therapy First Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises	Device: tDCS; tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function; Other Names: Transcranial direct current stimulation ; Other: BrainHQ; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory; Other Names: Computerized cognitive exercises

Outcome Measures

Primary Outcome Measures

1. Participant Retention in Combination Treatment [4 weeks]

   Number of participants completing every session of the combined phase of treatment

2. Participant-rated Acceptability of Combination Therapy [8 weeks]

   Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia

• Objective cognitive impairment in working memory

• Willingness to complete computerized cognitive training and undergo brain stimulation procedures

Exclusion Criteria:

• History of neurological illness or brain injury (e.g., stroke)

• History of loss of consciousness

• Diagnosed intellectual disability

• Current substance use disorder

• Current mania or moderate depression or severe psychosis

• Serious suicidal ideation/behavior

• Pregnant or trying to become pregnant, or currently lactating

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: Cynthia Burton, PhD, University of Michigan

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 23, 2020

More Information

Publications

None provided.

• Responsible Party: Cynthia Burton, Clinical Lecturer, Department of Psychiatry, University of Michigan
• ClinicalTrials.gov Identifier: NCT03338673
• Other Study ID Numbers: HUM00119204
• First Posted: Nov 9, 2017
• Last Update Posted: Sep 2, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Disease; Schizophrenia; Bipolar Disorder; Mood Disorders; Psychotic Disorders

Study Results

Participant Flow

Arm/Group Title	Dual Therapy First	Mono Therapy First
Arm/Group Description	Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory	Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Period Title: Overall Study
STARTED	6	6
COMPLETED	5	5
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Dual Therapy First	Mono Therapy First	Total
Arm/Group Description	Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory	Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory	Total of all reporting groups
Overall Participants	6	6	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.67 (13.98)	48.83 (13.41)	48.75 (13.06)
Sex: Female, Male (Count of Participants)
Female	5 83.3%	5 83.3%	10 83.3%
Male	1 16.7%	1 16.7%	2 16.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 50%	1 16.7%	4 33.3%
White	3 50%	5 83.3%	8 66.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Participant Retention in Combination Treatment
Description	Number of participants completing every session of the combined phase of treatment
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Therapy First	Mono Therapy First
Arm/Group Description	Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory	Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Measure Participants	6	6
Count of Participants [Participants]	4 66.7%	5 83.3%

2. Primary Outcome

Title	Participant-rated Acceptability of Combination Therapy
Description	Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dual Therapy First	Mono Therapy First
Arm/Group Description	Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory	Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Measure Participants	5	5
Mean (Standard Deviation) [units on a scale]	9.40 (0.89)	8.60 (2.07)

Adverse Events

Time Frame	8 weeks
Arm/Group Title	Dual Therapy First		Mono Therapy First
Arm/Group Description	Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory		Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises tDCS: tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function BrainHQ: BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
All Cause Mortality
	Dual Therapy First		Mono Therapy First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Serious Adverse Events
	Dual Therapy First		Mono Therapy First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Dual Therapy First		Mono Therapy First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)

Limitations/Caveats

[Not Specified]

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.