rTMS and Functional Paralysis (PARALYSTIM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
Collaborator:
University Hospital, Caen
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01352910
First received: May 11, 2011
Last updated: September 5, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of side effects occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1, D2 ] [ Designated as safety issue: Yes ]
  • Degree of side effects gravity occurred during the 2 days of rTMS, between D0 and D1 [ Time Frame: D0, D1 and D2 ] [ Designated as safety issue: Yes ]
  • Degree of paralysis at D60, quantified by an interview and a standardized examination [ Time Frame: D60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 94
Study Start Date: September 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352910

Contacts
Contact: Nathalie Chastan, MD PhD 0232888037 ext 0033 nathalie.chastan@chu-rouen.fr

Locations
France
Caen University Hospital Recruiting
Caen, France, 14000
Contact: Olivier Etard, MD PhD    0231064526 ext 0033    etard-o@chu-caen.fr   
Rouen University Hospital Recruiting
Rouen, France, 76031
Contact: nathalie chastan, MD PhD    0232888037 ext 0033    nathalie.chastan@chu-rouen.fr   
Sponsors and Collaborators
University Hospital, Rouen
University Hospital, Caen
Investigators
Principal Investigator: Nathalie Chastan, MD PhD Rouen University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01352910     History of Changes
Other Study ID Numbers: 2010/082/HP
Study First Received: May 11, 2011
Last Updated: September 5, 2014
Health Authority: France: Institutional Ethical Committee

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

ClinicalTrials.gov processed this record on October 23, 2014