Efficacy of Deep Transcranial Magnetic Stimulation (TMS) for Treatment-resistant Depression and Neuroanatomical Correlates: a Randomized Clinical Study Coupled With Positon Emission Tomography (PET)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
研究概览
简要总结
Repetitive transcranial magnetic stimulation (TMS) is an emergent non-invasive treatment for treatment resistant depression (TRD). The exact neuro-functional mechanisms related to TMS efficiency remains however unknown; besides local effect on the target, TMS may induce interaction changes between remote cerebral regions. On the other hand, few studies have been performed in comparison to sham placebo stimulation. The investigators recently showed that non-responder depressive patients to TMS exhibited deeper and wider brain functional abnormalities hardly reachable by standard coils. The H1-Coil is a novel TMS (H-TMS) device capable of inducing a magnetic field with a deeper and wider distribution than standard coils.
The investigators design here a randomized controlled study in which the investigators will compare the clinical effects of H-coil TMS and standard TMS in patients with TRD, and their functional neuroanatomical correlates and changes in connectivity by Positron Emission Tomography (PET). The general objective is to better understand the mechanisms related to TMS efficiency in pharmacoresistant depression, in order to propose the best therapeutic approach for the patient.
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
- 否
入选标准
- •Patients who met the diagnosis of major depressive episode (MDE)
- •Patient right-handed
- •Men and women aged over 18 years with major depressive episode IV (DSM-IV criteria), isolated or recurrent.
- •Scores on the scale MADRS> 20
- •Resistance Criterion defined as the failure of two antidepressants effective dose for a minimum of six weeks.
- •Drug Therapy stable for at least 2 weeks
排除标准
- •Bipolar disorder type I or type II
- •Depression With Psychotic Features
- •Diagnosis according comorbid Axis I (DSM IV) with schizophrenia, alcohol abuse and / or toxic substances.
- •Inpatient under stress or under legal protection measure (guardianship, curatorship)
- •Counter to the practice of Transcranial Magnetic Stimulation : a personal history of seizure, history of neurological or neurosurgical pathologies, metallic prosthetic material or foreign objects (pacemakers, prosthetic eye equipment, etc.).
- •Pregnant or breastfeeding ongoing.
- •Somatic disorder may affect cognitive abilities and brain structures
- •Known allergy to any component of Fludeoxyglucose
结局指标
主要结局
The depression score in Montgomery-Åsberg Depression Rating Scale (MADRS).
时间窗: 24 month
performed before and after TMS
次要结局
- Short self-completion questionnaire on symptoms of depression(24 month)