跳至主要内容
临床试验/NCT06050369
NCT06050369招募中不适用

Actimetric and Electrophysiological Analyses of Repetitive Behaviors (Tics and Compulsions)

Institut National de la Santé Et de la Recherche Médicale, France3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年12月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
3
主要终点
modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients

研究概览

简要总结

Introduction:

Repetitive behaviors (RB) constitute a broad range of symptoms across different psychiatric/neurologic disorders. The most famous are stereotypies (found in autism), compulsions (found in obsessive-compulsive-disorder, OCD) and tics (found in Gilles de la Tourette syndrome, GTS). For some patients, it is sometime difficult to distinguish the nature of the repetitive behaviors presented, however this distinction is crucial in order to chose the appropriate treatment.

Aim:

In our study, the investigators will try to define electrophysiological and accelerometric marker of both OCD and tics to allow objective distinction between both tics and compulsions.

Method:

Subjects: Both OCD and GTS patients will be recruited, 25 patients in each group.

Protocol: our study protocol will involve two step: a step in laboratory, another step at patient home.

  • first step: both patients group will be recorded through a high density EEG and a portative EEG while doing a task of symptom provocation. Then they will get an anatomical MRI for source recontruction. Finally, the patients will have to mimic their symptom while wearing an accelerometer (a smartwatch).
  • second step: both patient groups will be recorded at home through a portative EEG while tagging their symptom through a smartwatch (also used for accelerometry). After the recording, the patients will keep the smartwatch for 2 weeks, still tagging their sympoms (compulsions or tics).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
15 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • To be more of 15 years old or less than 65 years old
  • To suffer from OCD and/or GTS (depressive, anxious and attention deficit hyperactivity disorder (ADHD) comorbidities are accepted)
  • To be registered to the french social security (or something equivalent)
  • To give written consent to participate to the research
  • To have contraception for women participants (or to not have any sexual activity)

排除标准

  • Patients with any other psychiatric disorders than those mentioned in the inclusion criteria
  • Patients with any other neurological disorder than GTS
  • Patients who are not able to take decisions for themselves
  • Pregnant women
  • Patients not allowed to get MRI due to contraindication
  • Patients not speaking french

研究组 & 干预措施

GTS group

Experimental

This arm will be studied to get some electrophysiological marker of tics. The patients will be their own control (periods with symptoms vs. free symptoms periods).

干预措施: EEG (Device)

GTS group

Experimental

This arm will be studied to get some electrophysiological marker of tics. The patients will be their own control (periods with symptoms vs. free symptoms periods).

干预措施: MRI (Device)

OCD group

Experimental

This arm will be studied to get some electrophysiological marker of compulsions. The patients will be their own control (periods with symptoms vs. free symptoms periods).

干预措施: EEG (Device)

OCD group

Experimental

This arm will be studied to get some electrophysiological marker of compulsions. The patients will be their own control (periods with symptoms vs. free symptoms periods).

干预措施: MRI (Device)

结局指标

主要结局

modification of power (μV2) in EEG frequencies before compulsions in Obsessive-Compulsive Disorder patients

时间窗: one year

change in the power EEG frequencies in OCD patients before compulsions EEG frequencies come to 0 to 250 Hz, the power is the amplitude of oscillations

modification of power (μV2) in EEG frequencies before tics in Gilles de la Tourette patients

时间窗: one year

change in the power of EEG frequencies in GTS patients before tics EEG frequencies come to 0 to 250 Hz, the power is the amplitude of oscillations

次要结局

  • Difference in power (μV2) in EEG frequencies between obsessive-compulsive disorder patients and Gilles de la Tourette patients(One year and a half)
  • percentage (%) of compulsions and tics detected by accelerometer(One year and a half)
  • Correlation between number of compulsions detected by accelerometer and Y-BOCS scores get by obsessive-compulsive patients(One year and a half)
  • Correlation of EEG frequency power (arbitrary units) detected before compulsions and scores get with clinical scales (Y-BOCS)(One year and a half)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (3)

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