Gamma brain-feedback to boost working memory in schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, double-blind, placebo-controlled randomized trial enrolling adults with schizophrenia or schizoaffective disorder. Participants are randomized to active gamma EEG neurofeedback or sham feedback, twice weekly for 12 weeks, with 30 sessions total. The study measures working memory (N-back), frontal gamma coherence, global cognition, symptoms, and community functioning at multiple time points, plus follow-ups at 3 and 6 months after treatment. Primary analyses use mixed model repeated measures to compare outcomes between groups at Week 12. The trial builds on prior feasibility data and uses a CGX wireless headset to deliver real-time feedback of frontal gamma activity.

Why it matters

Who can join: the full rules

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

Where it's running

• UC San Diego School of Medicine
  La Jolla, California, United States Recruiting

Study contacts

• Principal investigator: Fiza Singh, MD — University of California, San Diego
• Study coordinator: Autumn Harris Study Coordinator
• Email: fnlab@health.ucsd.edu
• Phone: 858-267-2257

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.