Confirmatory Trial of Gamma Neurofeedback to Improve Working Memory in Schizophrenia
2026年5月11日 更新者：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.
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
104
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Autumn Harris Study Coordinator
- 电话号码：858-267-2257
- 邮箱：fnlab@health.ucsd.edu
研究联系人备份
- 姓名：Jason Holden Lab Manager, PhD
- 电话号码：858-267-2257
- 邮箱：fnlab@health.ucsd.edu
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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).
|
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.
其他名称：
|
|
假比较器：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.
|
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
N-back 2-back target accuracy (d-prime)
大体时间：Baseline to Week 12
|
Working memory performance on the N-back task (2-back condition), analyzed with mixed model repeated measures (MMRM).
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Baseline to Week 12
|
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Frontal gamma coherence during N-back task
大体时间：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
大体时间：Baseline to Week 12
|
Functional outcome assessing independent living skills relevant to community functioning.
|
Baseline to Week 12
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Fiza Singh, MD、University of California, San Diego
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2029年11月30日
研究完成 (估计的)
2030年5月31日
研究注册日期
首次提交
2026年5月11日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月18日
研究记录更新
最后更新发布 (实际的)
2026年5月18日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R01MH139831
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
Within 12 months of primary results publication (estimated 2031)
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.