rTMS and Functional Paralysis (PARALYSTIM)
Primary Purpose
Psychogenic Paralysis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
rTMS
Sham rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Psychogenic Paralysis
Eligibility Criteria
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)
Sites / Locations
- Caen University Hospital
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
effective rTMS
Sham rTMS
Arm Description
Outcomes
Primary Outcome Measures
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
Secondary Outcome Measures
Number of side effects occurred during the 2 days of rTMS, between D0 and D1
Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1
Degree of paralysis at D60, quantified by an interview and a standardized examination
Full Information
NCT ID
NCT01352910
First Posted
May 11, 2011
Last Updated
August 16, 2016
Sponsor
University Hospital, Rouen
Collaborators
University Hospital, Caen
1. Study Identification
Unique Protocol Identification Number
NCT01352910
Brief Title
rTMS and Functional Paralysis
Acronym
PARALYSTIM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
Collaborators
University Hospital, Caen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychogenic Paralysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
effective rTMS
Arm Type
Experimental
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
120 pulses 0.2 Hz
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Intervention Description
120 pulses 0.2 Hz
Primary Outcome Measure Information:
Title
Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators
Time Frame
D2
Secondary Outcome Measure Information:
Title
Number of side effects occurred during the 2 days of rTMS, between D0 and D1
Time Frame
D0, D1, D2
Title
Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1
Time Frame
D0, D1 and D2
Title
Degree of paralysis at D60, quantified by an interview and a standardized examination
Time Frame
D60
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Chastan, MD PhD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Learn more about this trial
rTMS and Functional Paralysis
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