Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With Schizophrenia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia; Schizoaffective
• Intervention / Treatment: Behavioral: Frontal gamma coherence neurofeedback; Behavioral: Placebo Neurofeedback

Detailed Description

In this preliminary placebo-controlled, double-blind randomized clinical trial (RCT), eligible participants will be randomized (block permutation) to either Active frontal coherence gamma neurofeedback (gcoh-NFB, n = 15) or Placebo neurofeedback (placebo-NFB, n = 15). All participants will present in person to Univ. of Ca. San Diego (UCSD) for Baseline assessments of primary and secondary outcome measures, and will receive training on self-administration of gcoh-NFB from home. All participants will be provided with mobile treatment platform, with instructions to practice gcoh-NFB from home twice weekly (30 minutes per session) for 12 weeks (24 sessions total). Study personnel will reach out to patient by phone and video at least weekly to facilitate gcoh-NFB self administration. Staff will be available by phone and video more frequently, as indicated by participant performance or preference. All participants will return to UCSD for midpoint (Week 6, or after 12 sessions) and end-of-treatment (Week 12, or after 24 session) in person assessments of primary and secondary outcome measures, and maintenance or return of mobile treatment platform. For participants randomized to Active gcoh-NFB, mobile treatment platform presents reinforcement signals coupled in real time to target neurobiological features. For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiza Singh, MD; Phone Number: 858-267-2257; Email: fnlab@health.ucsd.edu

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California San Diego
      • Contact: Fiza Singh, MD; Phone Number: 858-267-2257; Email: fnlab@health.ucsd.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active frontal gamma coherence neurofeedback	Behavioral: 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 Comparator: Placebo neurofeedback	Behavioral: Placebo Neurofeedback; For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: BioSignal Solutions LLC
• Collaborators: National Institute of Mental Health (NIMH); University of California, San Diego

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 17, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 17, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: neurofeedback; schizophrenia; EEG; gamma; working memory; mobile; digital; neurotechnology
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: BioSignal_2026_gcoh_NFB_0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be made publicly available. Because this SBIR-funded project involves translation of a proprietary EEG neurofeedback platform, the scientific data, device-use data, analytic outputs, and platform-related data are expected to include proprietary SBIR/STTR data. BioSignal Solutions LLC will preserve final research datasets and associated documentation internally to support NIH reporting, human-subjects oversight, regulatory development, intellectual-property protection, and scientific publications, as applicable. Aggregate findings may be disseminated through NIH reports, presentations, regulatory communications, and peer-reviewed publications. Any case-by-case sharing of data underlying a publication would be considered only if consistent with SBIR/STTR data rights, intellectual-property strategy, privacy protections, informed consent, IRB determinations, contractual obligations, applicable laws, and award terms.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No