NCT05111548

Brain Stimulation and Cognitive Training - Efficacy

Completed NA Results posted Last updated 9 May 2024

What this trial tests

NA trial testing tDCS (Active) in Schizophrenia in 19 participants. Completed in 12 May 2023.

Timeline

8 September 2021

Primary endpoint
14 April 2023

12 May 2023

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	19
Start date	8 September 2021
Primary completion	14 April 2023
Estimated completion	12 May 2023
Sites	1 location across United States

Drugs / interventions tested

• tDCS (Active)
• BrainHQ
• tDCS (Inactive)

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →
• Schizo Affective Disorder — all drugs for Schizo Affective Disorder →
• Bipolar Disorder — all drugs for Bipolar Disorder →

Sponsor

University of Michigan

Who can join

Adults 18 to 65, any sex, with Schizophrenia or Schizo Affective Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Letter-number Span Total Score Primary · 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).

Group	Value	95% CI
Active Stimulation + Cognitive Training	0.40	± 1.67
Inactive Stimulation + Cognitive Training	0.50	± 1.64

Change in Working Memory Performance - Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Spatial Span Total Score Primary · 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).

Group	Value	95% CI
Active Stimulation + Cognitive Training	1.60	± 0.89
Inactive Stimulation + Cognitive Training	0.17	± 1.60

Change in Non-Working Memory Comparison Measures - MCCB Trail Making Test, Part A Secondary · 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).

Group	Value	95% CI
Active Stimulation + Cognitive Training	1.40	± 5.55
Inactive Stimulation + Cognitive Training	2.33	± 7.17

Change in Non-Working Memory Comparison Measures - Trail Making Test, Part B Secondary · 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).

Group	Value	95% CI
Active Stimulation + Cognitive Training	3.60	± 12.82
Inactive Stimulation + Cognitive Training	19.50	± 17.76

Adverse events — posted to ClinicalTrials.gov

Time frame: Duration of participation in the study (i.e., up to 8 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Active Stimulation + Cognitive Training

Serious: 0/8 (0%)

Deaths: 0/8

Inactive Stimulation + Cognitive Training

Serious: 0/7 (0%)

Deaths: 0/7

Other adverse events (1 terms — click to expand)

Reaction	System	Active Stimulation + Cogni…	Inactive Stimulation + Cog…
Intense discomfort at stimulation site	Injury, poisoning and procedural complications	—	—

Data from ClinicalTrials.gov NCT05111548 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.