Brain Stimulation and Cognitive Training

Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Serious Mental Illness.

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Schizo Affective Disorder
• Intervention / Treatment: Device: tDCS; Other: BrainHQ

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dual Therapy First; 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; 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; Other: BrainHQ; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory; Other Names: Computerized cognitive exercises
Experimental: Mono Therapy First; 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; 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; Other: BrainHQ; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory; Other Names: Computerized cognitive exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Cynthia Burton, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): October 11, 2018
• Primary Completion (Actual): September 27, 2019
• Study Completion (Actual): September 27, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 2, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: HUM00119204

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes