NCT05111548

Brain Stimulation and Cognitive Training - Efficacy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Schizophrenia
• Schizo Affective Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
DEVICE	tDCS (Active)	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.
BEHAVIORAL	BrainHQ	BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
DEVICE	tDCS (Inactive)	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.

Timeline

• Start date: 2021-09-08
• Primary completion: 2023-04-14
• Completion: 2023-05-12
• First posted: 2021-11-08
• Last updated: 2024-05-09
• Results posted: 2024-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study