rTMS and Functional Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 3
- 主要终点
- Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
研究概览
简要总结
Psychogenic paralysis presents a real treatment challenge. Despite psychotherapy, physiotherapy, antidepressants, acupuncture or hypnosis, the outcome is not always satisfactory with persistent symptoms after long-term follow-up. In a preliminary retrospective study on 70 patients with psychogenic paralysis (44F/26M, mean age : 24.7 ± 16.6 ys), repetitive transcranial magnetic stimulation (rTMS) delivered over the motor cortex at low frequency was effective in 89% of cases (recovery: n=53, improvement: n=9), with an immediate or quasi-immediate recovery in 73% of patients (n=51).
We suggest that the dramatic improvement of psychogenic paralysis after rTMS could be due to the restoration of an appropriate cerebral connectivity by activating a suppressed motor cortex. Nevertheless, the possibility of a placebo effect cannot be ruled out.
A prospective multicentric (Rouen, Caen) randomized controlled trial versus placebo will be done for 94 patients with psychogenic paralysis, 1- to evaluate rTMS efficacy for paralysis at short and long term follow-up, and 2- to confirm rTMS safety. Two rTMS sessions will be performed at D0 and D1 (120 pulses over 2 days, delivered over the motor cortex at 2 Hz) with an active or a sham coil. Post-rTMS assessment will evaluate 1- the degree of the paralysis at D2 (quantified by a videotape) and D60 (quantified by an interview and a standardized examination), 2- the number and gravity of side effects.
If psychogenic paralysis improvement by motor cortex rTMS is confirmed, rTMS could be considered a useful early therapeutic option.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 14 years old
- •Psychogenic paralysis according to the DSM-IV-R
排除标准
- •Contra-indication of rTMS
- •Pregnancy or breast-feeding
- •Previous history of epilepsia
- •Previous session of rTMS (for any indication)
研究组 & 干预措施
effective rTMS
干预措施: rTMS (Device)
Sham rTMS
干预措施: Sham rTMS (Device)
结局指标
主要结局
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
时间窗: D2
次要结局
- Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1(D0, D1 and D2)
- Degree of paralysis at D60, quantified by an interview and a standardized examination(D60)
- Number of side effects occurred during the 2 days of rTMS, between D0 and D1(D0, D1, D2)
