Neuromodulation for a Novel OCD Biomarker and Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- YBOCS
研究概览
简要总结
Although multiple treatments for OCD exist, slow symptom decrease, high remission, and significant side effects for some OCD patients limit their efficacy. More research into the precise neural mechanisms and linked cognitive functions in OCD is also necessary. To address both concerns, this study by Dr. Reinhart and his team will test a new, non-invasive, and well-tolerated neuromodulation method for reducing OCD symptoms, based on reward-related rhythms of the orbitofrontal cortex (OFC; a brain region responsible for reward, decision making and other crucial functions that is affected by OCD). This proposal is based on highly encouraging preliminary data in both subsyndromal and treatment-resistant populations that shows rapid reductions in OCD behaviors that last at least 1-3 months. Using high-definition transcranial alternating current stimulation (HD-tACS) guided by EEG brain wave recordings, the study will test whether repetitive modulation of relevant rhythm activity in the OFC can lead to rapid (within five days) and sustainable (up to three months) OCD symptom reduction. This research aims to increase knowledge of OCD and development of effective treatment with minimal side effects.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) a primary DSM-5 diagnosis of OCD, (2) a score of 16 or greater on the YBOCS (3) at least 18 years of age; and (4) willingness and ability to provide informed consent and comply with the requirements of the study protocol.
排除标准
- •(1) a lifetime history of bipolar or psychotic disorders; (2) history of Tourette syndrome; (3) psychosurgery; (4) substance abuse or dependence (other than nicotine) in the past 3 months; (5) organic brain syndrome, mental retardation or other potentially interfering cognitive dysfunction; (6) severe depression (MADRS score of 30 or greater); (7) suicidal risk as determined by moderate or greater score on the Columbia Suicide Severity Rating Scale (C-SSRS); (8) pregnancy or lactation; (9) changes to pharmacotherapy for OCD or the initiation of cognitive-behavior therapy within the last 3 months; and (10) specific to the tACS and EEG procedures no metal implants in head, any implanted electronic devices, any skin sensitivity, color blindness or impaired vision despite correction, claustrophobia, and any history of epilepsy or neurological disorder.
研究组 & 干预措施
Sham HD-tACS
HD-tACS of OFC
干预措施: high definition transcranial alternating current stimulation (Device)
Active HD-tACS
HD-tACS of OFC
干预措施: high definition transcranial alternating current stimulation (Device)
结局指标
主要结局
YBOCS
时间窗: day 5 of intervention
There are 10 YBOCS questions scored 0 to 4. The total Y-BOCS score is the sum of items 1-10. A higher score is worse.
次要结局
- EEG beta-gamma rhythms(3 months after intervention)
- YBOCS(3 months after intervention)
研究者
Robert Reinhart
Associate Professor
Boston University Charles River Campus
