N/A N=8 Randomized Triple-blind Treatment

Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia

Schizophrenia · Psychosis

Bottom Line

View on ClinicalTrials.gov: NCT02975973 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Nov 2020

Primary outcome: Primary: tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: transcranial direct current stimulation (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Baylor College of Medicine
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging	—	—
PRIMARY tDCS Engagement of DLPFC Activity Indexed by Modulation of Frontal Cortical Gamma Oscillations	—	—
SECONDARY Optimal tDCS Strength for DLPFC Engagement	—	—
SECONDARY Tolerability and Feasibility of Multi-session tDCS in Schizophrenia	0; 50; 0; 100	—

Summary

Cognitive impairments in schizophrenia are the most debilitating aspect of the illness and poorly treated by current medications. This study investigates transcranial direct current stimulation (tDCS) - a safe, noninvasive weak electrical current delivery to stimulate brain function - as a novel therapeutic for cognition in schizophrenia. Integrating neurostimulation, electrophysiology and neuroimaging, this project aims to study tDCS effects on cognition by verifying therapeutic target engagement, evaluating the tolerability of tDCS sessions, and optimizing treatment parameters.

Eligibility Criteria

Inclusion Criteria

ages 18-35 years;
within first five years of antipsychotic treatment;
on stable doses of antipsychotic medication for at least one month;
Clinically stable as defined by Clinical Global Impression-Severity scale (CGI-S) less than or equal to 4 (moderately ill);
Mild to severe cognitive impairment in MATRICS Consensus Cognitive Battery (composite scores <40);
DSM-5 MINI 7.0.2 criteria for schizophrenia or schizoaffective by patient SCID

Exclusion Criteria

Mental retardation as defined by pre-morbid IQ by Wechsler Test of Adult Reading at screening <70 or Spanish Word Accentuation Test;
significant head injury;
History of severe medical or neurological illnesses
pregnancy or postpartum (<6 weeks after delivery or miscarriage);
inability to provide informed consent;
significant color blindness that affects task performance;
Positive urine drug screen (exception for marijuana) or presence of substance use disorder within 1 month;
Currently on benzodiazepines or mood stabilizers affecting GABA

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02975973). 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.