Randomized Controlled Trial of Two Accelerated Transcranial Magnetic Stimulation Methods in the Treatment of Resistant Depression: Intermittent Theta Burst Stimulation With an 8-Coil Versus H1-Coil
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- The response rate according to the MADRS scale
研究概览
简要总结
The goal of this clinical trial is to compare response rates after treatment with Figure Eight-Coil TMS versus H-Coil TMS on the prefrontal cortex left dorsolateral, in patients suffering from depression resistant. The main question it aims to answer is:
rTBS (accelerated neuronavigated intermittent Theta Burst Stimulation) is more effective than hTBS (accelerated deep intermittent Theta Burst Stimulation) in the treatment of resistant depression in terms of response rate.?
Researchers will compare Figure Eight-Coil TMS (rTBS) versus H-Coil TMS (hTBS) to see if rTBS is more effective than hTBS.
Participants will:
- Receive, for each stimulation method, 8 sessions per day spaced 50 minutes apart, over 5 days.
- Have visit all day of stimulation for checkups and tests.
- Have a a research MRI before and after treatment.
- Have follow-up visits at 1 month, 2 months, 3 months, 6 months, and 12 months post-treatment, via teleconsultation.
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
- Single (Investigator)
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 over 18 years of age
- •Presenting a major depressive episode according to the DSM-5-TR criteria, occurring as part of major depressive disorder (unipolar depression)
- •The major depressive episode must meet the criteria for treatment resistance, defined by a lack of response to at least two different antidepressant treatments prescribed at an effective dose for a duration of 6 weeks or more
- •Stable treatment for at least 6 weeks
- •Affiliation with a social security system or State Medical Assistance (Aide Médicale d'État)
- •Patient agrees to participate in the study and has signed an informed consent form
排除标准
- •Presence of a contraindication to TMS: epilepsy, intracranial foreign body, cochlear implant, retinal implant, pacemaker
- •Presence of a bipolar disorder according to DSM-5-TR criteria
- •Presence of catatonic or psychotic features during the current episode
- •Presence of severe psychiatric disorders other than a major depressive episode
- •Presence of neurological disorders
- •Unstable epilepsy
- •Current moderate to severe addiction disorders other than caffeine and/or tobacco
- •Current suicidal ideation
- •Use of any brain stimulation treatment (ECT, rTMS, tDCS) for the current episode
- •Pregnancy or breastfeeding
- •Women of childbearing potential without effective contraception
- •Persons under guardianship or legal protection
结局指标
主要结局
The response rate according to the MADRS scale
时间窗: Before the treatment and after the treatment at 5 day.
The response rate is defined as an improvement of more than 50% compared to baseline on the MADRS clinical scale (Montgomery-Asberg Depression Rating Scale). The MADRS consists of 10 items, each scored from 0 to 6 : depressive mood, appetite, sleep, psychomotor retardation, anxiety, suicidal thoughts, cognitive impairment, pessimism, loss of control and demoralization. The total score is the sum of the scores for all 10 items. The overall score can range from 0 to 60. 0 to 6: No depression 7 to 19: Mild depression 20 to 34: Moderate depression 35 to 60: Severe depression
次要结局
- Tolerance to treatment(Each visits of clinical trial : each day of treatment (5 days), at 1 month, 2 month, 3 month, 6 month and 12 month.)
- Pain detection and pain tolerance using an experimental pain task(Before the treatment and after the treatment at 5 day.)
- Clinical improvement of treatment-resistant depression(Before the treatment and after the treatment at 5 days.)
- Improvement of cognitive functions.(Before the treatment and after the treatment at 5 day.)
- Improvement of neurophysiological functions(Before the treatment and after the treatment at 5 day.)
研究者
Dominique JANUEL
Head of clinical research department
Centre hospitalier de Ville-Evrard, France