Schizophrenia Clinical Trial
Official title:
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.
Verified date | August 2020 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 27, 2019 |
Est. primary completion date | September 27, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant Retention in Combination Treatment | Number of participants completing every session of the combined phase of treatment | 4 weeks | |
Primary | 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 |
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