Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia
SCHIZOPHRENIA 1 (Disorder) · Schizoaffecitve Disorder
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 2
- Rango de edad
- 18 años - 55 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 104 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Leer la descripción completa
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).
¿Quién podría participar?
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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
Tratamiento, grupos y participación
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- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento triple
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
N-back 2-back target accuracy (d-prime)
Plazo: 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
Plazo: 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
Plazo: Baseline to Week 12
Functional outcome assessing independent living skills relevant to community functioning.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (1)
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1 centros
UC San Diego School of MedicineLa Jolla, California, United StatesReclutando
Equipo y fechas
- Patrocinador principal
- University of California, San Diego
- Inicio del estudio
- 5 nov 2026 Estimado
- Finalización primaria
- 30 nov 2029 Estimado
- Finalización del estudio
- 31 may 2030 Estimado
- Primera publicación
- 18 may 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
Confirmatory Efficacy Trial to Confirm the Effects of Gamma EEG-Neurofeedback on Working Memory in Schizophrenia
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026