rTMS and Functional Paralysis

Not Applicable

Completed

• Conditions: Psychogenic Paralysis

• Registration Number: NCT01352910
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Study Start: 2011-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators	D2

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Caen University Hospital; 🇫🇷 Caen, France

Rouen University Hospital; 🇫🇷 Rouen, France