Effects of rTMS Over Right COF Blood Perfusion in OCD Patients: an ASL Double Blinded Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Cerebral Blood Flow of the Orbito-Frontal Cortex from Arterial Spin Labeling Data
研究概览
简要总结
This study will focus on the use of repetitive Transcranial Magnetic Stimulation (rTMS) as a treatment of Obsessive Compulsive Disorder (OCD), which is a common illness that impairs quality of life and that can be hard to treat.
To precisely analyze the effects of rTMS on OCD, the investigators are going to plan a study comparing cerebral blood flow before and after rTMS treatment. The measuring will occur on the Orbito Frontal Cortex (OFC), whose role in OCD has already been shown by our team (Nauczyciel et al, 2014 in Translational Psychiatry), using Magnetic Resonance Imaging in Arterial Spin Labeling, an MRI method allowing to measure arteriola blood flow.
Our primary outcome is to show a significate difference between cerebral blood flow in OCD between one group of participants treated by rTMS and another one treated by placebo. The study will be double blinded with a placebo rTMS machine, monocentric and prospective, with participants suffering from OCD randomized between two groups.
详细描述
Obsessive Compulsive Disorders (OCD) are a frequent and debilitating disease. Impact on daily life is usually important, with a high rate of mood and anxious comorbidities, such as Major Depressive Disorder occurring in half of these participants. The effects can be dramatic, leading to higher suicide rate in this population.
Guidelines for OCD treatment in France recommend the use of Serotonin Specific Recapture Inhibitors (SSRI) and Cognitive Behavioral Therapy (CBT), if possible simultaneously. However, those treatments are responsible for adverse effects for the first and not easily accessible for the second. Consequently, a non-negligible number of participants still suffers from symptoms of OCD with a non-optimal treatment.
Repetitive Transcranial Magnetic Stimulation (rTMS), a noninvasive neurostimulation method, has shown its usefulness in the treatment of mental illnesses. It has been authorized by the Food and Drugs Administration in the United States for the treatment of OCD. It represents an alternative method for helping those participants, but pattern of modifications over OCD pathophysiology has still to be unraveled.
In order to precisely analyze the effects of Low Frequency rTMS (LF rTMS) on OCD, the investigators designed a monocentric, prospective, double blind study comparing cerebral blood flow (CBF) before and after a rTMS treatment. Measurements will be performed on the Orbito Frontal Cortex (OFC), whose role in OCD has already been shown by our team (Nauczyciel et al, 2014 in Translational Psychiatry), using Magnetic Resonance Imaging (MRI) in Arterial Spin Labeling (ASL).
Inclusion criteria will be OCD diagnosis, age between 18 and 65, and the lack of counter indication to MRI and rTMS. Participants will firstly undergo MRI before treatment, along with a psychometric assessment. Participants will then receive a one-week rTMS treatment, with two sessions of fifteen minutes per day. Second MRI and evaluation will be performed 4 weeks after the end of the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The masking model will use the same rTMS coil as the active group, bit with a 180° rotation, making the magnetic field face the opposite direction, and thus not being able to produce Neuromodulation on the patient. The stimulation intensity will be decreased at 30% of the motor threshold, to keep the characteristic sound of active rTMS. The patient will not know their group; neither will the investigator nor the rater. Only the rTMS performing technician will know the randomization group to be able to choose the right setting.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants over 18 to 65
- •Score at YBOCS over 15
- •Diagnosis of Obsessive Compulsive Disorder acknowledged by two psychiatrists using the DSM V criteria
- •Patient is able to receive and understand information about the trial, and agrees to participate in the trial
- •Indication of treatment by rTMS
排除标准
- •Related to MRI and / or rTMS:
- •Cardiac Stimulator or Implantable Automatic Defibrillator
- •Neurosurgical Clips
- •Cochlear Implant
- •Intra ocular or cranial metallic foreign body
- •Endoprosthesis lasting from less than four weeks
- •Ostheosynthesis material lasting from less than six weeks
- •Claustrophobia
- •Other criteria:
- •Pregnancy or breast feeding
- •Unstable hemodynamics, acute respiratory failure, need for constant surveillance not possible during the MRI, precarious general condition
- •Patient over legal protection, care without consent
- •Active psychiatric pathology other than anxious or mood disorder
- •Active severe somatic disease
- •History of seizures or other neurologic pathologies (Parkinson's Disease, CVA, Alzheimer's Disease, Multiple Sclerosis, Lewy Body Dementia...)
- •Patient without social security
研究组 & 干预措施
Sham rTMS
The investigators will perform sham rTMS at 30% of the Motor Threshold, with a 1Hz frequency and 1200 pulses during one session. The target will be the right Orbito Frontal Cortex, localized using Neuronavigation. Sessions will last fifteen minutes; subjects will perform two sessions a day during five days. The coil will have a 180° rotation compared to the active coil position, thus making the magnetic field ineffective on the patient's cortex.
Participants will undergo a MRI with anatomical and ASL sequences one week before and four weeks after treatment.
All participants of this group will have the opportunity to undergo an active rTMS treatment right after the end of each one's participation in the study.
干预措施: Sham rTMS (Other)
Active rTMS
The investigators will perform active rTMS at 120% of the Motor Threshold, with a 1Hz frequency and 1200 pulses during one session. The target will be the right Orbito Frontal Cortex, localized using Neuronavigation. Sessions will last fifteen minutes; subjects will perform two sessions a day during five days.
Participants will undergo a MRI with anatomical and ASL sequences one week before and four weeks after treatment
干预措施: Active rTMS (Other)
结局指标
主要结局
Cerebral Blood Flow of the Orbito-Frontal Cortex from Arterial Spin Labeling Data
时间窗: one measure four weeks after end of treatment
Comparison between the sham rTMS group and the active rTMS group will be analyzed from the ASL data about cerebral blood flow in the Orbito-Frontal Cortex. We expect to find a significant difference between the two groups four weeks after the treatment on the mean of cerebral blood flow, as raw data will be converted into numerical data for analysis.
次要结局
- Score at Hamilton Anxiety Rating Scale (HAMA)(one measure before treatment, one four weeks after end of treatment)
- Intra Group CBF Comparison(one measure before treatment, one four weeks after end of treatment)
- Score at Clinical Global Impression scale (CGI)(one measure before treatment, one four weeks after end of treatment)
- Score at Montgomery and Asberg Depression Rating Scale (MADRS)(one measure before treatment, one four weeks after end of treatment)
- Score at Yale-Brown Obsessive Compulsive Scale (YBOCS)(one measure before treatment, one four weeks after end of treatment)
- Blindness Evaluation(measure will occur four weeks after the treatment, at the same assessment than clinical outcomes)
- Score at General Assessment Functioning Scale (GAF)(one measure before treatment, one four weeks after end of treatment)