Brain Stimulation and Cognitive Training

Study Overview
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Brief Summary
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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.

Official Title
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Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.

Conditions
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Bipolar Disorder, Schizo Affective Disorder, Schizophrenia

Intervention / Treatment
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* Device: tDCS
* Other: BrainHQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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 condition
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dual Therapy First<br>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<br>* tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function<br>* Other names: Transcranial direct current stimulation;Other: BrainHQ<br>* BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory<br>* Other names: Computerized cognitive exercises;|
| Experimental: Mono Therapy First<br>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<br>* tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function<br>* Other names: Transcranial direct current stimulation;Other: BrainHQ<br>* BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory<br>* Other names: Computerized cognitive exercises;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Retention in Combination Treatment | Number of participants completing every session of the combined phase of treatment | 4 weeks | 
| Participant-rated Acceptability of Combination Therapy | Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction) | 8 weeks |