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临床试验/NCT01352910
NCT01352910已完成不适用

rTMS and Functional Paralysis

University Hospital, Rouen3 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

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

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

Experimental

干预措施: rTMS (Device)

Sham rTMS

Sham Comparator

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)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (3)

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