Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

ConditionsSchizophrenia Schizoaffective

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-55

SponsorBioSignal Solutions LLC

About this trial

This preliminary, randomized, double-blind, placebo-controlled clinical trial will evaluate frontal gamma coherence neurofeedback in adults with schizophrenia. Thirty participants will be randomly assigned to receive either active neurofeedback or placebo neurofeedback using a study-provided mobile platform. Participants will complete baseline assessments in person at the University of California San Diego, receive training on home use of the neurofeedback platform, and complete twice-weekly 30-minute sessions at home for 12 weeks. Participants will return for midpoint and end-of-treatment assessments to evaluate feasibility, tolerability, cognitive outcomes, and neurophysiological target engagement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntary informed consent to participate and capacity to consent as measured by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC1) instrument;

Age 18 to 55;

Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review;

Clinically stable as operationalized by (a) not having been admitted to a psychiatric hospital within the three months prior to assessment, (b) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (c) ascertained to be clinically and medically stable by one of the study investigators

Disqualifiers

Electroconvulsive therapy within six months of the baseline assessment;

Medical conditions that can impact cognition, including self-reported history of seizure disorder; multiple sclerosis; stroke or major vascular disease; HIV/AIDS; brain cancer; prior head injury involving loss of consciousness;

Current (but not past) major depression;

Substance use disorder other than nicotine or caffeine in the past year;

Trial design

Design model

Parallel

Treatments tested in this trial

Frontal gamma coherence neurofeedback
Device
Frontal gamma coherence neurofeedback (gcoh-NFB) uses electroencephalographic (EEG) to reward active maintenance of gamma coherence recorded at frontal F3 and F4 electrode sites (from the International 10-20 System for EEG electrode placement).
Placebo Neurofeedback
Device
For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: Active frontal gamma coherence neurofeedbackActive comparator 1 intervention

Group B: Placebo neurofeedbackPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint

Total accuracy, across target and nontarget trials, for the 2-Back condition, during N-Back testing (calculated as percent of responses correct; lowest possible accuracy, 0; highest possible accuracy, 100; higher accuracy corresponds to higher working memory performance)

Time frame

Baseline (Week 0) to Endpoint (Week 12)

Sponsors and contacts

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BioSignal Solutions LLC

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

University of California, San Diego

Collaborator

Source ClinicalTrials.gov

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