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rTMS and Functional Paralysis (PARALYSTIM)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01352910
First Posted: May 12, 2011
Last Update Posted: August 17, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Rouen
  Purpose

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 Intervention
Psychogenic Paralysis Device: rTMS Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Degree of paralysis at D2, quantified by a videotape made at D2 and interpreted by to independent examinators [ Time Frame: D2 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 66
Study Start Date: September 2011
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: effective rTMS Device: rTMS
120 pulses 0.2 Hz
Sham Comparator: Sham rTMS Device: Sham rTMS
120 pulses 0.2 Hz

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Caen University Hospital
Caen, France, 14000
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
University Hospital, Caen
Investigators
Principal Investigator: Nathalie Chastan, MD PhD Rouen University Hospital
  More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01352910     History of Changes
Other Study ID Numbers: 2010/082/HP
First Submitted: May 11, 2011
First Posted: May 12, 2011
Last Update Posted: August 17, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms