Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

NCT07659938 | Not Yet Recruiting DMC

• 1 other identifier: BioSignal_2026_gcoh_NFB_0001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizoaffective

Keywords

schizophrenia; working memory; gamma; EEG; neurofeedback; mobile; digital; neurotechnology

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline (Week 0) to Endpoint (Week 12)

Study Arms (2)

Active frontal gamma coherence neurofeedback

ACTIVE COMPARATOR

Behavioral: Frontal gamma coherence neurofeedback

Placebo neurofeedback

PLACEBO COMPARATOR

Behavioral: Placebo Neurofeedback

Interventions

Frontal gamma coherence neurofeedback BEHAVIORAL

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).

Active frontal gamma coherence neurofeedback

Placebo Neurofeedback BEHAVIORAL

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

Placebo neurofeedback

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;
• Inability to read or speak English (with corrected vision or hearing if needed);
• Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device;
• Uncooperativeness with the laboratory assessment protocol leading to missing data;
• Color blindness that interferes with assessment;
• Testing in the past 6 months on the cognitive measures

Sponsors & Collaborators

• BioSignal Solutions LLC: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, San Diego: collaborator

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Fiza Singh, MD

CONTACT

858-267-2257; fnlab@health.ucsd.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)