N/A
Completed N=8
Prefrontal Cortical Engagement Through Non-Invasive Brain Stimulation in Schizophrenia
Source: ClinicalTrials.gov NCT02975973 ↗Enrolled (actual)
8
Serious AEs
12.5%
Results posted
Nov 2020
Primary outcomePrimary: tDCS Engagement of DLPFC Activity Indexed by fMRI BOLD Imaging
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.
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 | — |
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
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. Informational only — not medical advice.