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Brain Stimulation and Cognitive Training - Efficacy

Sponsor
University of Michigan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05111548
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
12.7
Anticipated Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS
  • Behavioral: BrainHQ
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness
Actual Study Start Date :
Sep 8, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active stimulation + cognitive training

Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).

Device: tDCS
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
Other Names:
  • transcranial direct current stimulation

    • Behavioral: BrainHQ
    BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
    Other Names:
  • cognitive training
  • computerized cognitive exercises

    		•
    Sham Comparator: Inactive stimulation + cognitive training

    Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).

    Behavioral: BrainHQ
    BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
    Other Names:
  • cognitive training
  • computerized cognitive exercises

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Verbal working memory performance [change from baseline to post-treatment (2-4 weeks)]

      MATRICS Consensus Cognitive Battery (MCCB) letter-number span total score

    2. Visual working memory performance [change from baseline to post-treatment (2-4 weeks)]

      MCCB spatial span total score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Michigan Ann Arbor Michigan United States 48109

    Sponsors and Collaborators

    • University of Michigan

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cynthia Burton, Clinical Assistant Professor, Department of Psychiatry, University of Michigan
    ClinicalTrials.gov Identifier:
    NCT05111548
    Other Study ID Numbers:
    • HUM00119204b
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Disease
    Schizophrenia
    Bipolar Disorder
    Mood Disorders
    Psychotic Disorders

    Study Results

    No Results Posted as of Nov 8, 2021