Confirmatory Efficacy Trial to Confirm the Effects of Gamma EEG-Neurofeedback on Working Memory in Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 104
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)
- •Age 18-55 years
- •Clinically stable: no psychiatric hospitalization in the 3 months prior to enrollment
- •No change in antipsychotic medication type or dosage within 4 weeks prior to baseline assessment
- •Ascertained to be clinically and medically stable by a study investigator
- •Does not meet DSM-5 diagnostic criteria for bipolar disorder or current major depressive episode
- •No electroconvulsive therapy (ECT) within 6 months of baseline assessment
- •Able to read and speak English (corrected vision or hearing aids acceptable)
- •Able and willing to provide written informed consent
排除标准
- •1. Self-reported history of seizure disorder
- •Diagnosed with multiple sclerosis
- •History of stroke or major vascular disease, including insulin-dependent diabetes mellitus
- •HIV/AIDS diagnosis
- •Current (not past) major depressive episode
- •Substance use disorder other than nicotine use disorder or caffeine use disorder in the past year
- •Brain cancer (primary or metastatic)
- •Prior head injury involving loss of consciousness
- •Inability to read or speak English
- •Color blindness that interferes with administration of study assessments
- •Neuropsychological or cognitive testing in the past 6 months using the same measures as this study
- •Score on Letter-Number Sequencing greater than 1 standard deviation above the age-normed mean
研究者
Fiza Singh
Associate Professor
University of California, San Diego