Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia (NCT07592169) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia
104 participantsStarted 2026-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dev…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing gamma neurofeedback to improve working memory in schizophrenia and schizoaffective disorder, and it's not yet recruiting — can you help me understand what gamma neurofeedback actually involves, and whether this approach makes sense given where I am in my treatment right now?
2Since this is a Phase 2 trial, the researchers are still building evidence on how well it works and confirming its safety profile — what does that mean for me in terms of what is and isn't yet known about the risks or benefits?
3The trial is measuring something called the N-back working memory test and also real-world living skills through the Independent Living Skills Survey — does my current level of cognitive difficulty seem like it would be a realistic fit for what this study is trying to test?
4Since the trial isn't recruiting yet, is it worth waiting for it to open, or are there established treatments or other studies available now that could address my working memory problems more immediately?
5Would taking part in this trial, which involves neurofeedback sessions and cognitive testing, be something that realistically fits into my current schedule and treatment plan, especially if I'm already managing medications or other therapies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
N-back 2-back target accuracy (d-prime)
Timeframe: Baseline to Week 12
2
Frontal gamma coherence during N-back task
Timeframe: Baseline to Week 12
3
Independent Living Skills Survey (ILSS) total score