rTMS and Functional Paralysis (PARALYSTIM)
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|ClinicalTrials.gov Identifier: NCT01352910|
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : August 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Psychogenic Paralysis||Device: rTMS Device: Sham rTMS|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Study Start Date :||September 2011|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
|Experimental: effective rTMS||
120 pulses 0.2 Hz
|Sham Comparator: Sham rTMS||
Device: Sham rTMS
120 pulses 0.2 Hz
- Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators [ Time Frame: D2 ]
- Number of side effects occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1, D2 ]
- Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1 and D2 ]
- Degree of paralysis at D60, quantified by an interview and a standardized examination [ Time Frame: D60 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352910
|Caen University Hospital|
|Caen, France, 14000|
|Rouen University Hospital|
|Rouen, France, 76031|
|Principal Investigator:||Nathalie Chastan, MD PhD||Rouen University Hospital|