Brain Stimulation and Cognitive Training

NCT03338673 | Completed Results FDA Device

• 1 other identifier: HUM00119204
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

People with serious mental illness often report 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 acceptable to participants, and whether it is helpful in improving a specific type of memory skill in people who have mental health conditions and memory deficits. This study is designed so that all participants will get both treatments: the non-invasive brain stimulation and computerized cognitive exercises. Half of the participants will start with both the brain stimulation and the cognitive exercises (dual therapy), and half will start with just the computerized exercises (monotherapy). After three weeks, participants will switch to the other condition: the people who did both treatments first will switch to just the cognitive exercises alone, and the people who started with the cognitive exercises alone will then switch to doing both the brain stimulation and cognitive exercises. Overall, participants will be in the study for about 7-8 weeks. The brain stimulation treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also complete paper-and-pencil assessments at the beginning, middle, and end of treatment.

Conditions

Bipolar Disorder; Schizo Affective Disorder; Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Participant Retention in Combination Treatment

  Number of participants completing every session of the combined phase of treatment

  4 weeks

• Participant-rated Acceptability of Combination Therapy

  Self-reported satisfaction as indicated on a numerical rating scale (1-10, where higher scores indicate greater satisfaction)

  8 weeks

Study Arms (2)

Dual Therapy First

EXPERIMENTAL

Participants receive 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises (BrainHQ), followed by 10 hours of computerized cognitive exercises alone

Device: tDCS; Other: BrainHQ

Mono Therapy First

EXPERIMENTAL

Participants complete 10 hours of computerized cognitive exercises (BrainHQ) alone, followed by 10 sessions of non-invasive brain stimulation (tDCS) plus 10 hours of computerized cognitive exercises

Device: tDCS; Other: BrainHQ

Interventions

tDCS 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

Also known as: Transcranial direct current stimulation

Dual Therapy First; Mono Therapy First

BrainHQ OTHER

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

Also known as: Computerized cognitive exercises

Dual Therapy First; Mono Therapy First

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
• Objective cognitive impairment in working memory
• Willingness to complete computerized cognitive training and undergo brain stimulation procedures

You may not qualify if:

• History of neurological illness or brain injury (e.g., stroke)
• History of loss of consciousness
• Diagnosed intellectual disability
• Current substance use disorder
• Current mania or moderate depression or severe psychosis
• 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

Bipolar Disorder; Psychotic Disorders; Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

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

czburton@umich.edu

7347639259

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: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer, Department of Psychiatry

Model Details: Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 9, 2017
• Study Start: October 11, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: September 2, 2020
• Results First Posted: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)