跳至主要内容
临床试验/NCT02704117
NCT02704117进行中(未招募)3 期

Neurocircuitry of OCD: Effects Of Modulation

Butler Hospital2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2015年6月最近更新:
适应症

试验速览

阶段
3 期
状态
进行中(未招募)
入组人数
19
试验地点
2
主要终点
Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)

研究概览

简要总结

The purpose of this study is to test the effects of non-invasive neuromodulation, transcranial magnetic stimulation on brain function in individuals with obsessive-compulsive disorder (OCD). This study is focused on the mechanism(s) by which brain stimulation might change the functioning of regions implicated in OCD, and thereby inform possible future therapeutic uses.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Current primary OCD diagnosis and current Y-BOCS total score of ≥16
  • 18-70 years of age
  • Ability to speak, read, write, and understand English sufficiently well to complete study procedures and provide informed consent
  • No use of psychiatric medications or stable psychiatric medication use for a minimum of 6 week prior to study entry
  • Ongoing psychotherapy allowed if already established for three months or more before study entry

排除标准

  • History of primary psychotic disorder or bipolar disorder
  • Present acute suicidality
  • History of head injury, epilepsy, or other clinically significant neurological illness except tic disorders
  • Active systemic medical (metabolic, endocrine, chronic inflammatory, vascular, autoimmune) disease
  • Premorbid intelligence quotient (IQ) estimate < 80
  • Visual disturbance (<20/40 Snellen visual acuity, corrected)
  • Current, or alcohol or illicit substance abuse/dependence in the last 3 months
  • Contraindications to TMS or MRI: metallic foreign objects, e.g., aneurysm clips/pacemakers, or questionable history of metal fragments, claustrophobia
  • Women who are pregnant or breastfeeding. All women participants of reproductive age are required to have a negative pregnancy test prior to enrollment and use medically acceptable birth control throughout the study (barrier and/or oral contraceptives)
  • Current psychotic symptoms
  • An increased risk of seizure, determined by history
  • Medications judged to notably affect cortical excitability e.g., anticonvulsants or high-dose benzodiazepines (> 4 mg/day of clonazepam or equivalent)
  • Predominant hoarding symptoms

结局指标

主要结局

Change in activation of pre-supplementary motor area/dorsal anterior cingulate cortex (pSMA/dACC) on functional magnetic resonance imaging (fMRI) during the Multi-Source Interference task (MSIT)

时间窗: Baseline and 6 months

次要结局

  • Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)(Baseline and 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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