NCT03338673

Brain Stimulation and Cognitive Training

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bipolar Disorder
• Schizo Affective Disorder
• Schizophrenia

Interventions

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

Timeline

• Start date: 2018-10-11
• Primary completion: 2019-09-27
• Completion: 2019-09-27
• First posted: 2017-11-09
• Last updated: 2020-09-02
• Results posted: 2020-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study