Preliminary Placebo-Controlled Double-Blind Randomized Clinical Trial of Mobile Platform to Improve Memory From Home or Office for Patients With Schizophrenia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint
研究概览
简要总结
This preliminary, randomized, double-blind, placebo-controlled clinical trial will evaluate frontal gamma coherence neurofeedback in adults with schizophrenia. Thirty participants will be randomly assigned to receive either active neurofeedback or placebo neurofeedback using a study-provided mobile platform. Participants will complete baseline assessments in person at the University of California San Diego, receive training on home use of the neurofeedback platform, and complete twice-weekly 30-minute sessions at home for 12 weeks. Participants will return for midpoint and end-of-treatment assessments to evaluate feasibility, tolerability, cognitive outcomes, and neurophysiological target engagement.
详细描述
In this preliminary placebo-controlled, double-blind randomized clinical trial (RCT), eligible participants will be randomized (block permutation) to either Active frontal coherence gamma neurofeedback (gcoh-NFB, n = 15) or Placebo neurofeedback (placebo-NFB, n = 15). All participants will present in person to Univ. of Ca. San Diego (UCSD) for Baseline assessments of primary and secondary outcome measures, and will receive training on self-administration of gcoh-NFB from home. All participants will be provided with mobile treatment platform, with instructions to practice gcoh-NFB from home twice weekly (30 minutes per session) for 12 weeks (24 sessions total). Study personnel will reach out to patient by phone and video at least weekly to facilitate gcoh-NFB self administration. Staff will be available by phone and video more frequently, as indicated by participant performance or preference. All participants will return to UCSD for midpoint (Week 6, or after 12 sessions) and end-of-treatment (Week 12, or after 24 session) in person assessments of primary and secondary outcome measures, and maintenance or return of mobile treatment platform. For participants randomized to Active gcoh-NFB, mobile treatment platform presents reinforcement signals coupled in real time to target neurobiological features. For participants randomized to Placebo-NFB, mobile treatment platform presents reinforcement signals recorded previously during active gcoh-NFB sessions from other participants.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Voluntary informed consent to participate and capacity to consent as measured by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC1) instrument;
- •Age 18 to 55;
- •Meet DSM-5 criteria for a current diagnosis of schizophrenia or schizoaffective disorder based on a SCID-5 interview and available medical record review;
- •Clinically stable as operationalized by (a) not having been admitted to a psychiatric hospital within the three months prior to assessment, (b) having had no change in antipsychotic medication dosage within four weeks prior to the baseline assessment, and (c) ascertained to be clinically and medically stable by one of the study investigators
排除标准
- •Electroconvulsive therapy within six months of the baseline assessment;
- •Medical conditions that can impact cognition, including self-reported history of seizure disorder; multiple sclerosis; stroke or major vascular disease; HIV/AIDS; brain cancer; prior head injury involving loss of consciousness;
- •Current (but not past) major depression;
- •Substance use disorder other than nicotine or caffeine in the past year;
- •Inability to read or speak English (with corrected vision or hearing if needed);
- •Unable to adequately see or manually manipulate a smartphone, tablet or other mobile device;
- •Uncooperativeness with the laboratory assessment protocol leading to missing data;
- •Color blindness that interferes with assessment;
- •Testing in the past 6 months on the cognitive measures
研究组 & 干预措施
Active frontal gamma coherence neurofeedback
干预措施: Frontal gamma coherence neurofeedback (Behavioral)
Placebo neurofeedback
干预措施: Placebo Neurofeedback (Behavioral)
结局指标
主要结局
Change in 2-Back Accuracy During N-Back Testing From Baseline to Endpoint
时间窗: Baseline (Week 0) to Endpoint (Week 12)
Total accuracy, across target and nontarget trials, for the 2-Back condition, during N-Back testing (calculated as percent of responses correct; lowest possible accuracy, 0; highest possible accuracy, 100; higher accuracy corresponds to higher working memory performance)
次要结局
未报告次要终点