Recruiting
Phase 2

Gamma EEG-NFB

Sponsor:

UCLA

Code:

NCT07592169

Conditions

SCHIZOPHRENIA 1 (Disorder)

Schizoaffecitve Disorder

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

EEG Neurofeedback

Study Details

Brief summary:

This study is a confirmatory, double-blind, placebo-controlled randomized clinical trial (RCT) testing whether gamma EEG neurofeedback (EEG-NFB) improves working memory in adults with schizophrenia or schizoaffective disorder. Participants are randomly assigned to receive either active gamma EEG-NFB (real-time feedback of frontal gamma brain activity) or sham EEG-NFB (false pre-recorded feedback), twice weekly for 12 weeks. Working memory (N-back task), brain gamma coherence, and everyday community functioning are assessed at baseline, mid-treatment, end of treatment, and follow-up.

Conditions

SCHIZOPHRENIA 1 (Disorder)

Schizoaffecitve Disorder

Study ID

NCT07592169

Start date

Nov 5, 2026

Status verified date

May, 2026

Completion date

May 31, 2030

Anticipated

Primary completion date

Nov 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 1\. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) 2. Age 18-55 years 3. Clinically stable: no psychiatric hospitalization in the 3 months prior to enrollment 4. No change in antipsychotic medication type or dosage within 4 weeks prior to baseline assessment 5. Ascertained to be clinically and medically stable by a study investigator 6. Does not meet DSM-5 diagnostic criteria for bipolar disorder or current major depressive episode 7. No electroconvulsive therapy (ECT) within 6 months of baseline assessment 8. Able to read and speak English (corrected vision or hearing aids acceptable) 9. Able and willing to provide written informed consent

Exclusion Criteria:

  • 1\. Self-reported history of seizure disorder 2. Diagnosed with multiple sclerosis 3. History of stroke or major vascular disease, including insulin-dependent diabetes mellitus 4. HIV/AIDS diagnosis 5. Current (not past) major depressive episode 6. Substance use disorder other than nicotine use disorder or caffeine use disorder in the past year 7. Brain cancer (primary or metastatic) 8. Prior head injury involving loss of consciousness 9. Inability to read or speak English 10. Color blindness that interferes with administration of study assessments 11. Neuropsychological or cognitive testing in the past 6 months using the same measures as this study 12. Score on Letter-Number Sequencing greater than 1 standard deviation above the age-normed mean

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Gamma EEG-NFB

Participants receive real-time gamma EEG neurofeedback targeting frontal gamma coherence (F3 and F4 electrodes, 30-50 Hz) via a CGX wireless 32-electrode headset. Each session includes a 1-minute resting baseline followed by two 15-minute training blocks. Positive reinforcement (images and music) is contingent on meeting an individualized gamma coherence threshold. Sessions are twice weekly for 12 weeks (30 total sessions).

sham comparator: Sham EEG-NFB

Participants undergo identical procedures to the active arm including EEG electrode placement and the same session structure, twice weekly for 12 weeks. However, the feedback displayed is pre-recorded from prior participants and has no relationship to the participant's own brain activity. Participants and outcome assessors are blinded to group assignment.

Interventions

EEG Neurofeedback

Gamma EEG neurofeedback delivered via CGX/Cognionics wireless headset (FDA cleared for research use). Active arm receives real-time gamma coherence feedback; sham arm receives pre-recorded feedback unrelated to own brain activity.

Primary outcome measure

  • N-back 2-back target accuracy (d-prime) [ Time Frame: Baseline to Week 12 ]
  • Frontal gamma coherence during N-back task [ Time Frame: Baseline to Week 12 ]
  • Independent Living Skills Survey (ILSS) total score [ Time Frame: Baseline to Week 12 ]

Central Contacts and Locations

Central contacts

Autumn Harris Study Coordinator

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

Jason Holden Lab Manager, PhD

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

Locations

UC San Diego School of Medicine

Recruiting

La Jolla, California, United States, 92037

Contacts

Autumn Harris

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

More Information

Sponsor

University of California, San Diego

Last update posted

Nov 10, 2026

Last verified

May, 2026

Keywords

  • schizophrenia
  • neurofeedback
  • EEG
  • gamma oscillations
  • working memory
  • randomized controlled trial
  • n-back
  • community functioning

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-11. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2026-11-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.