Brain Stimulation and Cognitive Training - Efficacy

Study Overview
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Brief Summary
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People with serious mental illness often experience 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 helpful in improving a specific type of memory skill in people who have mental health conditions. The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training. Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.

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

Conditions
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Schizophrenia, Schizo Affective Disorder, Bipolar Disorder

Intervention / Treatment
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* Device: tDCS (Active)
* Behavioral: BrainHQ
* Device: tDCS (Inactive)


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 Willingness to participate in study procedures Exclusion Criteria: History of neurological illness or injury (e.g., stroke) History of loss of consciousness Diagnosed intellectual disability Current substance use disorder Current mania or moderate depression or severe psychosis Current 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: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active stimulation + cognitive training<br>Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ). | Device: tDCS (Active)<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. Participants in the experimental arm will receive a steady current delivery through the device.<br>* Other names: transcranial direct current stimulation;Behavioral: 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;|
| Sham Comparator: Inactive stimulation + cognitive training<br>Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ). | Behavioral: 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;Device: tDCS (Inactive)<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. Participants in the sham arm will wear the device but will not receive a steady current delivery.<br>* Other names: transcranial direct current stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal working memory performance | MATRICS Consensus Cognitive Battery (MCCB) letter-number span total score | change from baseline to post-treatment (2-4 weeks) | 
| Visual working memory performance | MCCB spatial span total score | change from baseline to post-treatment (2-4 weeks) |