rTMS and Functional Paralysis (PARALYSTIM)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
- Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators [ Time Frame: D2 ] [ Designated as safety issue: No ]
- Number of side effects occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1, D2 ] [ Designated as safety issue: Yes ]
- Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1 and D2 ] [ Designated as safety issue: Yes ]
- Degree of paralysis at D60, quantified by an interview and a standardized examination [ Time Frame: D60 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Experimental: effective rTMS||
120 pulses 0.2 Hz
|Sham Comparator: Sham rTMS||
Device: Sham rTMS
120 pulses 0.2 Hz
Please refer to this study by its ClinicalTrials.gov identifier: NCT01352910
|Contact: Nathalie Chastan, MD PhD||0232888037 ext firstname.lastname@example.org|
|Caen University Hospital||Recruiting|
|Caen, France, 14000|
|Contact: Olivier Etard, MD PhD 0231064526 ext 0033 email@example.com|
|Rouen University Hospital||Recruiting|
|Rouen, France, 76031|
|Contact: nathalie chastan, MD PhD 0232888037 ext 0033 firstname.lastname@example.org|
|Principal Investigator:||Nathalie Chastan, MD PhD||Rouen University Hospital|