Brain Stimulation and Cognitive Training

Not Applicable

Completed

• Conditions: Schizo Affective Disorder; Bipolar Disorder; Schizophrenia
• Interventions: Device: tDCS; Other: BrainHQ

• Registration Number: NCT03338673
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-06
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-09
• Study Start: 2018-10-11
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Status Verified: 2020-08
• Results First Submitted: 2020-08-14
• Results First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Results First Posted: 2020-09-02
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Dual Therapy First	tDCS	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
Dual Therapy First	BrainHQ	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
Mono Therapy First	tDCS	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
Mono Therapy First	BrainHQ	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

Primary Outcome Measures

Name	Time	Method
Participant Retention in Combination Treatment	4 weeks	Number of participants completing every session of the combined phase of treatment
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)

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States