Frontal Gamma Coherence Neurofeedback for Patients With Schizophrenia

Part of paid clinical trials in La Jolla, California.

Sponsor
BioSignal Solutions LLC
Study ID
NCT07659938
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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).
  • 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

Study Details

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.

Key Dates

Start date
Apr 30, 2027
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active frontal gamma coherence neurofeedback
  • Placebo Comparator: Placebo neurofeedback

Primary Outcome Measure

Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint [ Time Frame: Baseline (Week 0) to Endpoint (Week 12) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093
Fiza Singh, MD
858-267-2257

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