Clinical trial NCT05111548: Brain Stimulation and Cognitive Training - Efficacy
Official title: Neuromodulation Plus Cognitive Training to Improve Working Memory Among Individuals With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizo Affective Disorder
Bipolar Disorder
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score
timeFrame: Baseline to post-treatment (up to 4 weeks)
measure: Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score
timeFrame: Baseline to post-treatment (up to 4 weeks)
Secondary outcomes:
measure: Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A
timeFrame: Baseline to post-treatment (up to 4 weeks)
measure: Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B
timeFrame: Baseline to post-treatment (up to 4 weeks)
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cynthia Burton, PhD
role: PRINCIPAL_INVESTIGATOR
References: