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RecruitingNCT07592169ClinicalTrials.gov record

Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia

SCHIZOPHRENIA 1 (Disorder) · Schizoaffecitve Disorder

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type
Interventional
Phase
Phase 2
Age range
18 years - 55 years
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
104 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Read the full description

Schizophrenia is associated with deficits in gamma frequency (30-45 Hz) neural synchrony and working memory that are resistant to antipsychotic treatment. EEG neurofeedback (EEG-NFB) targeting frontal gamma coherence is a non-invasive approach that may restore gamma synchrony and improve working memory by reinforcing endogenous neural oscillations in real time.

This confirmatory RCT builds on a successful pilot trial (R33) demonstrating feasibility and preliminary efficacy of gamma EEG-NFB in schizophrenia. Participants (N=104) are randomized 1:1 to active gamma EEG-NFB or sham EEG-NFB. Active EEG-NFB delivers real-time feedback of frontal gamma coherence (F3/F4, 30-50 Hz) via a CGX wireless headset. Sham participants undergo identical procedures but receive pre-recorded feedback unrelated to their own brain activity. Both groups complete 30 sessions over 12 weeks (two sessions per week).

Co-primary outcomes are working memory (N-back d-prime) and frontal gamma coherence, assessed at baseline and Week 12. Secondary outcomes include global cognition, symptoms (PANSS), negative symptoms (CAINS), and community functioning (ILSS, UPSA-Brief, SFS). Follow-up assessments are conducted at 3 months (Week 24) and 6 months (Week 36) post-treatment. Primary analysis uses mixed model repeated measures (MMRM).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Triple masked
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).

Behavioral: EEG Neurofeedback

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.

Behavioral: EEG Neurofeedback

EEG Neurofeedback BEHAVIORAL

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

N-back 2-back target accuracy (d-prime)

Time frame: Baseline to Week 12

Working memory performance on the N-back task (2-back condition), analyzed with mixed model repeated measures (MMRM).

Frontal gamma coherence during N-back task

Time frame: Baseline to Week 12

EEG-derived frontal gamma coherence (30-50 Hz, F3-F4) measured during 2-back task performance.

Independent Living Skills Survey (ILSS) total score

Time frame: Baseline to Week 12

Functional outcome assessing independent living skills relevant to community functioning.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

UC San Diego School of MedicineLa Jolla, California, United StatesRecruiting

Study team and timeline

Lead sponsor
University of California, San Diego
Study start
Nov 5, 2026 Estimated
Primary completion
Nov 30, 2029 Estimated
Study completion
May 31, 2030 Estimated
First posted
May 18, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

Autumn Harris Study CoordinatorCONTACTfnlab@health.ucsd.edu858-267-2257
Jason Holden Lab Manager, PhDCONTACTfnlab@health.ucsd.edu858-267-2257
Official study title

Confirmatory Efficacy Trial to Confirm the Effects of Gamma EEG-Neurofeedback on Working Memory in Schizophrenia

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026