N/A N=15 Randomized Double-blind Treatment

Brain Stimulation and Cognitive Training - Efficacy

Schizophrenia · Schizo Affective Disorder · Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05111548 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2024

Primary outcome: Primary: Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score — 0.40; 0.50 score on a scale — p=0.923

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: tDCS (Active) (Device); BrainHQ (Behavioral); tDCS (Inactive) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Apr 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score	0.40; 0.50	0.923
PRIMARY Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score	1.60; 0.17	0.110
SECONDARY Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A	1.40; 2.33	0.818
SECONDARY Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B	3.60; 19.50	0.130

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05111548). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.