Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUniversity of California, San Diego
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
EEG Neurofeedback
BehavioralGamma 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.
Treatment groups
104 Participants
are divided into 2 treatment groupsGroup A: Gamma EEG-NFBExperimental treatment 1 intervention
Group B: Sham EEG-NFBSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
N-back 2-back target accuracy (d-prime)
Working memory performance on the N-back task (2-back condition), analyzed with mixed model repeated measures (MMRM).
Time frame
Baseline to Week 122
Frontal gamma coherence during N-back task
EEG-derived frontal gamma coherence (30-50 Hz, F3-F4) measured during 2-back task performance.
Time frame
Baseline to Week 123
Independent Living Skills Survey (ILSS) total score
Functional outcome assessing independent living skills relevant to community functioning.
Time frame
Baseline to Week 12Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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