Trial Outcomes & Findings for Improving Cognition in Schizophrenia Using tDCS (NCT NCT02539797)

Results Overview

Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

baseline and 20 minutes

Results posted on

2018-03-07

Participant Flow

Participant milestones

Participant milestones
Measure	Anodal Cathodal Sham anodal stimulation, followed by cathodal stimulation, followed by sham stimulation	Cathodal Sham Anodal cathodal stimulation, followed by sham stimulation, followed by anodal stimulation	Sham Anodal Cathodal sham stimulation, followed by anodal stimulation, followed by cathodal stimulation
Overall Study STARTED	12	13	13
Overall Study COMPLETED	12	12	13
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Anodal Cathodal Sham anodal stimulation, followed by cathodal stimulation, followed by sham stimulation	Cathodal Sham Anodal cathodal stimulation, followed by sham stimulation, followed by anodal stimulation	Sham Anodal Cathodal sham stimulation, followed by anodal stimulation, followed by cathodal stimulation
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=38 Participants tDCS: comparing anodal, cathodal, and sham tDCS
Age, Continuous	42.7 years STANDARD_DEVIATION 8.57 • n=38 Participants
Sex: Female, Male Female	12 Participants n=38 Participants
Sex: Female, Male Male	26 Participants n=38 Participants
Region of Enrollment United States	38 participants n=38 Participants

PRIMARY outcome

Timeframe: baseline and 20 minutes

Summary score of the cognitive domains on the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB). Four nonsocial neurocognitive tasks were included: speed of processing, working memory, verbal memory, and reasoning/problem solving. Normed T-scores were calculated for each cognitive subdomain, as well as the cognitive composite score consisting of the average across the four subdomains. The T-scores have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of higher cognition.

Outcome measures

Outcome measures
Measure	tDCS Anodal Stimulation n=37 Participants anodal stimulation tDCS: comparing anodal, cathodal, and sham tDCS	tDCS Cathodal Stimulation n=37 Participants cathodal stimulation tDCS: comparing anodal, cathodal, and sham tDCS	Sham Stimulation n=37 Participants Termination of electrical stimulation following 30 seconds tDCS: comparing anodal, cathodal, and sham tDCS
Change From Baseline in Cognition on MCCB	45.0 T-scores Standard Error 1.65	45.2 T-scores Standard Error 1.65	45.8 T-scores Standard Error 1.64

PRIMARY outcome

Timeframe: baseline and 20 minutes

Total score on the Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) The test consists of 141 items and 8 ability subtests, which assess four components of emotional processing. In this study, only branches 1 and 4 were administered, focusing on the Managing Emotions component. The total score reflects mean performance across the branches. The scores were converted to normed T-scores that have a mean of 50, with a difference of 10 points from the mean equaling one standard deviation. Higher T-scores are indicative of better performance.

Outcome measures

Outcome measures
Measure	tDCS Anodal Stimulation n=37 Participants anodal stimulation tDCS: comparing anodal, cathodal, and sham tDCS	tDCS Cathodal Stimulation n=37 Participants cathodal stimulation tDCS: comparing anodal, cathodal, and sham tDCS	Sham Stimulation n=37 Participants Termination of electrical stimulation following 30 seconds tDCS: comparing anodal, cathodal, and sham tDCS
Change From Baseline in Managing Emotions on MSCEIT	36.4 T-scores Standard Error 2.06	37.7 T-scores Standard Error 2.05	37.1 T-scores Standard Error 2.05

Adverse Events

tDCS Anodal Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

tDCS Cathodal Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Yuri Rassovsky

University of California, Los Angeles

Phone: 3104783711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place