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Completed

NCT Number: NCT05111548

Brain Stimulation and Cognitive Training - Efficacy

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.

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Key information

Age range

18 year–65 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
  • 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

Treatment and study plan

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.

Other names: transcranial direct current stimulation

BrainHQ

Behavioral

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

Other names: cognitive training, computerized cognitive exercises

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.

Other names: transcranial direct current stimulation

Primary outcomes

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

    Time frame: Baseline to post-treatment (up to 4 weeks)

    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).

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

    Time frame: Baseline to post-treatment (up to 4 weeks)

    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).

Secondary outcomes

  1. Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A

    Time frame: Baseline to post-treatment (up to 4 weeks)

    The Trail Making Test, part A is a subtest of the standardized MCCB and a measure of visuomotor processing/sequencing speed. Examinees must draw a line connecting numbers in ascending order as quickly as possible. Completion time in seconds is recorded (0-120, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).

  2. Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B

    Time frame: Baseline to post-treatment (up to 4 weeks)

    Trail Making Test, part B is not part of the standardized MCCB, but is commonly administered alongside part A as a measure of speeded visuomotor switching/flexibility. Examinees must draw a line connecting numbers and letters in alternating order (e.g., 1-A-2-B). Completion time in seconds is recorded (0-300, where lower scores represent better performance). For change scores, a positive value indicates improvement (i.e., faster completion time).

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 Severe Mental Illness

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 8, 2021
Registry last updated
May 9, 2024

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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