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Clinical Trials/NCT05111548
NCT05111548
Completed
Not Applicable

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

University of Michigan1 site in 1 country19 target enrollmentSeptember 8, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
University of Michigan
Enrollment
19
Locations
1
Primary Endpoint
Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 8, 2021
End Date
May 12, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cynthia Burton

Clinical Assistant Professor, Department of Psychiatry

University of Michigan

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score

Time Frame: Baseline to post-treatment (up to 4 weeks)

MCCB spatial span total raw score. Spatial span is a subtest of the standardized MCCB and a measure of visual working memory. Examinees must tap sequences of blocks in the same order as the examiner then in reverse. Correct responses are summed for the forward and backward condition to create a total raw score (0-32, where higher scores indicate better performance).For change scores, a positive value indicates improvement (i.e., higher total score).

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score

Time Frame: Baseline to post-treatment (up to 4 weeks)

MCCB letter-number span total raw score. Letter-number span is a subtest of the standardized MCCB and a measure of verbal working memory. Examinees must reorder sequences of numbers and letters spoken out loud by the examiner. Correct responses are counted to create a total score (0-24, where higher scores indicate better performance). For change scores, a positive value indicates improvement (i.e., higher total score).

Secondary Outcomes

  • Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A(Baseline to post-treatment (up to 4 weeks))
  • Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B(Baseline to post-treatment (up to 4 weeks))

Study Sites (1)

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