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N/A N=12 Randomized Other

Brain Stimulation and Cognitive Training

Bipolar Disorder · Schizo Affective Disorder · Schizophrenia

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Participant Retention in Combination Treatment — 4; 5 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
tDCS (Device); BrainHQ (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Michigan
Primary completion
Sep 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Participant Retention in Combination Treatment
4; 5
PRIMARY
Participant-rated Acceptability of Combination Therapy
9.40; 8.60

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03338673). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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