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rTMS and Functional Paralysis (PARALYSTIM)

U

University Hospital, Rouen

Status

Completed

Conditions

Psychogenic Paralysis

Treatments

Device: rTMS
Device: Sham rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01352910
2010/082/HP

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age > 14 years old
  • Psychogenic paralysis according to the DSM-IV-R

Exclusion criteria

  • Contra-indication of rTMS
  • Pregnancy or breast-feeding
  • Previous history of epilepsia
  • Previous session of rTMS (for any indication)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

66 participants in 2 patient groups

effective rTMS
Experimental group
Treatment:
Device: rTMS
Sham rTMS
Sham Comparator group
Treatment:
Device: Sham rTMS

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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