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Clinical Trials in the USA / NCT07659938
Starting soon Not applicable

Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

NCT07659938 · tracked via the Priya Life Science USA tracker
Sponsor
BioSignal Solutions LLC
Phase
Not applicable
Started
2027-04
Last updated
2026-09-24

Condition(s) studied

SchizophreniaSchizoaffective

Investigational drug(s) / intervention(s)

Frontal gamma coherence neurofeedbackPlacebo Neurofeedback

Frontal gamma coherence neurofeedback: 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: For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants

Study summary

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

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. Age 18 to 55; 3. Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review; 4. 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 Exclusion Criteria: 1. Electroconvulsive therapy within six months of the baseline assessment; 2. 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; 3. Current (but not past) major depression; 4. Substance use disorder other than nicotine or caffeine in the past year; 5. Inability to read or speak English (with corrected vision or hearing if needed); 6. Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device; 7. Uncooperativeness with the laboratory assessment protocol leading to missing data; 8. Color blindness that interferes with assessment; 9. Testing in the past 6 months on the cognitive measures

Primary outcome measure(s)

  • Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint — Baseline (Week 0) to Endpoint (Week 12)
    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)

Trial sites (1)

FacilityCityRegionStatus
University of California San Diego La Jolla California

Other trials for the same condition

Study of SPG302 in Adults With Schizophrenia Active, not recruiting
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A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT Recruiting
Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT) Recruiting
Zyprexa® Relprevv™ Patient Care Program Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07659938 on ClinicalTrials.gov ↗ ← All trials in the USA