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OpenTrials
Completed

NCT Number: NCT03338673

Brain Stimulation and Cognitive Training

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Transcranial direct current stimulation

BrainHQ

Other

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

Other names: Computerized cognitive exercises

Primary outcomes

  1. Participant Retention in Combination Treatment

    Time frame: 4 weeks

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

  2. Participant-rated Acceptability of Combination Therapy

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 9, 2017
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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