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Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia

11. maj 2026 opdateret af: Fiza Singh, University of California, San Diego

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

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

104

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Adfærdsmæssigt: 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.
Andre navne:
  • EEG NFB
Sham-komparator: 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.
Adfærdsmæssigt: 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.
Andre navne:
  • EEG NFB

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
N-back 2-back target accuracy (d-prime)
Tidsramme: Baseline to Week 12
Working memory performance on the N-back task (2-back condition), analyzed with mixed model repeated measures (MMRM).
Baseline to Week 12
Frontal gamma coherence during N-back task
Tidsramme: Baseline to Week 12
EEG-derived frontal gamma coherence (30-50 Hz, F3-F4) measured during 2-back task performance.
Baseline to Week 12
Independent Living Skills Survey (ILSS) total score
Tidsramme: Baseline to Week 12
Functional outcome assessing independent living skills relevant to community functioning.
Baseline to Week 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, San Diego

Efterforskere

  • Ledende efterforsker: Fiza Singh, MD, University of California, San Diego

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

30. november 2029

Studieafslutning (Anslået)

31. maj 2030

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R01MH139831

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data will be shared via the NIMH Data Archive (NDA) in accordance with the NIH Data Management and Sharing Plan submitted with R01MH139831. Data will be made available no later than the time of primary results publication.

IPD-delingstidsramme

Within 12 months of primary results publication (estimated 2031)

IPD-delingsadgangskriterier

De-identified individual participant data and supporting documents will be available to qualified researchers who submit a data access request through the NIMH Data Archive (NDA) at https://nda.nih.gov. Requestors must complete a Data Use Certification (DUC) agreeing to conditions of use including protecting participant confidentiality, not attempting to re-identify participants, and not sharing data outside the approved research team. Access is reviewed and approved by the NDA Data Access Committee.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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