Brain Stimulation and Cognitive Training
Primary Purpose
Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
BrainHQ
Sponsored by
About this trial
This is an interventional other trial for Bipolar Disorder
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Dual Therapy First
Mono Therapy First
Arm 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
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
Outcomes
Primary Outcome Measures
Participant Retention in Combination Treatment
Number of participants completing every session of the combined phase of treatment
Participant-rated Acceptability of Combination Therapy
Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)
Secondary Outcome Measures
Full Information
NCT ID
NCT03338673
First Posted
November 6, 2017
Last Updated
August 14, 2020
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03338673
Brief Title
Brain Stimulation and Cognitive Training
Official Title
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 11, 2018 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Schizo Affective Disorder, Schizophrenia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dual Therapy First
Arm Type
Experimental
Arm 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
Arm Title
Mono Therapy First
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
Transcranial direct current stimulation
Intervention Description
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
Intervention Type
Other
Intervention Name(s)
BrainHQ
Other Intervention Name(s)
Computerized cognitive exercises
Intervention Description
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Primary Outcome Measure Information:
Title
Participant Retention in Combination Treatment
Description
Number of participants completing every session of the combined phase of treatment
Time Frame
4 weeks
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Burton, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Stimulation and Cognitive Training
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