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Brain Stimulation and Cognitive Training - Efficacy

Primary Purpose

Schizophrenia, Schizo Affective Disorder, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS (Active)
BrainHQ
tDCS (Inactive)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active stimulation + cognitive training

Inactive stimulation + cognitive training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Verbal working memory performance
MATRICS Consensus Cognitive Battery (MCCB) letter-number span total score
Visual working memory performance
MCCB spatial span total score

Secondary Outcome Measures

Full Information

First Posted
October 1, 2021
Last Updated
May 12, 2023
Sponsor
University of Michigan
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1. Study Identification

Unique Protocol Identification Number
NCT05111548
Brief Title
Brain Stimulation and Cognitive Training - Efficacy
Official Title
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 8, 2021 (Actual)
Primary Completion Date
April 14, 2023 (Actual)
Study Completion Date
May 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active stimulation + cognitive training
Arm Type
Experimental
Arm Description
Participants receive 10 sessions of 'active' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
Arm Title
Inactive stimulation + cognitive training
Arm Type
Sham Comparator
Arm Description
Participants receive 10 sessions of 'inactive' non-invasive brain stimulation (tDCS) with concurrent cognitive training (BrainHQ).
Intervention Type
Device
Intervention Name(s)
tDCS (Active)
Other Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BrainHQ
Other Intervention Name(s)
cognitive training, computerized cognitive exercises
Intervention Description
BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Intervention Type
Device
Intervention Name(s)
tDCS (Inactive)
Other Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal working memory performance
Description
MATRICS Consensus Cognitive Battery (MCCB) letter-number span total score
Time Frame
change from baseline to post-treatment (2-4 weeks)
Title
Visual working memory performance
Description
MCCB spatial span total score
Time Frame
change from baseline to post-treatment (2-4 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brain Stimulation and Cognitive Training - Efficacy

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