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rTMS and Functional Paralysis (PARALYSTIM)

This study has been completed.
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Rouen Identifier:
First received: May 11, 2011
Last updated: August 16, 2016
Last verified: August 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 Intervention
Psychogenic Paralysis Device: rTMS Device: Sham rTMS

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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


Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT01352910

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

Responsible Party: University Hospital, Rouen Identifier: NCT01352910     History of Changes
Other Study ID Numbers: 2010/082/HP
Study First Received: May 11, 2011
Last Updated: August 16, 2016

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on June 22, 2017