University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT05111548
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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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Other names: cognitive training, computerized cognitive exercises
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
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).
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).
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).
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).
University of Michigan
Other
Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness
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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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