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Clinical Trial

rTMS and Functional Paralysis

NCT: NCT01352910 · COMPLETED

NCT IDNCT01352910
StatusCOMPLETED
Start Date2011-09
Completion2016-07

Brief Summary

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.

Frequently Asked Questions

What is rTMS and Functional Paralysis?

rTMS and Functional Paralysis is a clinical trial registered under NCT01352910. Current status: COMPLETED.

What is the status of NCT01352910?

The current status of NCT01352910 (rTMS and Functional Paralysis) is: COMPLETED.

When did rTMS and Functional Paralysis start?

rTMS and Functional Paralysis started on 2011-09.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.