Brain Stimulation and Cognitive Training - Efficacy

NCT05111548 | Completed Results FDA Device

• 1 other identifier: HUM00119204b
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizo Affective Disorder; Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

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

  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).

  Baseline to post-treatment (up to 4 weeks)

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

  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).

  Baseline to post-treatment (up to 4 weeks)

Secondary Outcomes (2)

• 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 Arms (2)

Active stimulation + cognitive training

EXPERIMENTAL

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

Device: tDCS (Active); Behavioral: BrainHQ

Inactive stimulation + cognitive training

SHAM COMPARATOR

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

Behavioral: BrainHQ; Device: tDCS (Inactive)

Interventions

tDCS (Active) DEVICE

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.

Also known as: transcranial direct current stimulation

Active stimulation + cognitive training

BrainHQ BEHAVIORAL

BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory

Also known as: cognitive training, computerized cognitive exercises

Active stimulation + cognitive training; Inactive stimulation + cognitive training

tDCS (Inactive) DEVICE

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.

Also known as: transcranial direct current stimulation

Inactive stimulation + cognitive training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
• Willingness to participate in study procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Cynthia Burton
• Organization: University of Michigan

czburton@med.umich.edu

734-615-9821

Study Officials

• Cynthia Burton, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Department of Psychiatry

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 8, 2021
• Study Start: September 8, 2021
• Primary Completion: April 14, 2023
• Study Completion: May 12, 2023
• Last Updated: May 9, 2024
• Results First Posted: May 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)