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Brain Stimulation and Cognitive Training - Efficacy

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ClinicalTrials.gov Identifier: NCT05111548
Recruitment Status : Recruiting
First Posted : November 8, 2021
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Cynthia Burton, University of Michigan

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
Schizophrenia Schizo Affective Disorder Bipolar Disorder Device: tDCS (Active) Behavioral: BrainHQ Device: tDCS (Inactive) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 8, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

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 (Active)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the experimental arm will receive a steady current delivery through the device.
Other Name: 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

Device: tDCS (Inactive)
tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function. Participants in the sham arm will wear the device but will not receive a steady current delivery.
Other Name: transcranial direct current stimulation




Primary Outcome Measures :
  1. Verbal working memory performance [ Time Frame: change from baseline to post-treatment (2-4 weeks) ]
    MATRICS Consensus Cognitive Battery (MCCB) letter-number span total score

  2. Visual working memory performance [ Time Frame: change from baseline to post-treatment (2-4 weeks) ]
    MCCB spatial span total score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05111548


Contacts
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Contact: Cynthia Burton, PhD 734-615-9821 czburton@umich.edu

Locations
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United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Cynthia Burton, PhD    877-864-3637    czburton@umich.edu   
Sponsors and Collaborators
University of Michigan
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Responsible Party: Cynthia Burton, Clinical Assistant Professor, Department of Psychiatry, University of Michigan
ClinicalTrials.gov Identifier: NCT05111548    
Other Study ID Numbers: HUM00119204b
First Posted: November 8, 2021    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Disease
Schizophrenia
Bipolar Disorder
Mood Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders