Prediction of the Response to a Course of Transcranial Magnetic Stimulation (rTMS) Based on the Acute Variation in Heart Rate Variability Obtained After a Single RTMS Session in Patients with Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- GCS CIPS
- 入组人数
- 160
- 试验地点
- 9
- 主要终点
- Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
研究概览
简要总结
Changes in heart rate variability following a single session of rTMS will be tested as a predictor of response to a course of 30 rTMS sessions in patients with major depressive disorder (MDD).
详细描述
The objective of this study is to investigate whether acute changes in heart rate variability following a single session of repetitive transcranial magnetic stimulation (rTMS) can predict the response to a 30-session course of rTMS in patients with major depressive disorder (MDD) with good sensitivity and specificity. Patients who are prescribed rTMS to treat an episode of MDD at one of the nine participating centres will be invited to participate in the study. The protocol includes one inclusion visit and seven evaluation visits before, during, and after the course of rTMS. The rTMS course will last for six weeks, comprising of 30 sessions with five sessions per week. Prior to the start of the rTMS course, the patient will have to fill in a number of questionnaires. Before the first session, heart rate variability will be assessed by recording the RR interval at rest using a heart rate belt on the armchair stimulation. A second RR interval recording will be taken immediately after the first rTMS session. Patients will answer questionnaires weekly and after the final rTMS session to track the progression of depressive symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Having a prescription for a course of rTMS to treat an episod of MDD
- •Unipolar MDD confirmed according to DSM-5 criteria
- •Moderate to severe MDD (MADRS score > 19)
- •No use of psychotropic medication or use stabilised (no change in dose < 4 weeks before study entry)
- •Able to understand, speak, read and write French
- •Express informed consent, after a period of reflection
- •Affiliated with a French social security scheme or beneficiary of such a scheme
- •Exclusion criteria:
- •History of epilepsy or convulsive seizures
- •Previous brain surgery
- •History of recent cranial trauma (< 6 months)
- •Presence of severe suicidal ideation
- •Psychotic disorders
- •Metal objects in the head, eyes or brain
- •Implanted ferromagnetic equipment (pace maker, cochlear implant, etc.)
- •Clinical evidence of serious or uncontrolled alcohol or substance use disorders in the three months prior to the study
- •Active withdrawal from alcohol or other substances
- •One or more recent rTMS sessions (< 4 weeks)
- •Other non-drug therapy recently initiated (< 4 weeks) to treat MDD (psychotherapy, phototherapy, vagus nerve stimulation, etc.)
- •Prescription of cardiotropic drugs belonging to the following classes: predominantly cardiac calcium channel blockers, Vaughan Williams class I anti-arrhythmics and beta-blockers.
- •Subjects in a period of relative exclusion from another protocol
- •Adults protected by law or patients under guardianship or curatorship
- •Subjects deprived of their liberty by judicial or administrative decision
- •Pregnant or breast-feeding women
排除标准
- 未提供
结局指标
主要结局
Threshold of variation in terms of RMSSD between normal heartbeats enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.
时间窗: One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions)
Threshold of variation in terms of RMSSD (root mean square of successive differences) between normal heartbeats after a single rTMS session enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity. The response to the course of rTMS will be assessed via the evolution of the MADRS score (decrease of MADRS score \>50%)
次要结局
- Threshold of variation in heart rate variability markers enabling to predict the remission to the course of rTMS with the best possible sensitivity and specificity.(One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions))
- Threshold of other heart rate variability markers enabling to predict the response to the course of rTMS with the best possible sensitivity and specificity.(One day for heart rate variability records (Before and after the first rTMS session), and 6 weeks for assessing the MADRS scores (before and after the course of 30 rTMS sessions))