Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
66 participants
INTERVENTIONAL
2011-09-30
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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effective rTMS
rTMS
120 pulses 0.2 Hz
Sham rTMS
Sham rTMS
120 pulses 0.2 Hz
Interventions
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rTMS
120 pulses 0.2 Hz
Sham rTMS
120 pulses 0.2 Hz
Eligibility Criteria
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Inclusion Criteria
* Psychogenic paralysis according to the DSM-IV-R
Exclusion Criteria
* Pregnancy or breast-feeding
* Previous history of epilepsia
* Previous session of rTMS (for any indication)
14 Years
ALL
No
Sponsors
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University Hospital, Caen
OTHER
University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Nathalie Chastan, MD PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Rouen
Locations
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Caen University Hospital
Caen, , France
Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2010/082/HP
Identifier Type: -
Identifier Source: org_study_id
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