Inhibitory rTMS in Dystonic Wilson Patients

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Brief Title

Inhibitory rTMS in Dystonic Wilson Patients

Official Title

Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation

Brief Summary

      Wilson disease is a genetic disorder resulting in copper accumulation in liver, brain and
      eye. The neurologic complications include dystonic syndrome, which is a prolonged and
      excessive muscle activation responsible for abnormal postures. Hand dystonia prevents daily
      life activities such as writing, which is particularly disabling, since writing is the only
      mean of communication in these patients with significant slurred speech. Treatment is limited
      and only partially effective.

      Low frequency (					

Detailed Description

      This study investigates the handwriting performance of an homogeneous cohort of patients with
      Wilson disease and right handed dystonia, after one single inhibitory repetitive transcranial
      magnetic stimulation (rTMS). Fifteen patients with focal right hand dystonia will receive
      randomly either active or sham rTMS (1 Hz) to the left somatosensory cortex (SSC) in one
      single 20 minutes session. Handwriting performance will be measured immediately after this
      unique session (Visual analogic scale of subjective discomfort in writing, DPRE and WCRS
      scales, pen pressure and pen velocity measured on touchpad), compared to scores obtained 24
      hours before the session. Three days later, the patient will receive the other session (sham
      rTMS or active rTMS) and the same parameters will be evaluated.

      This is a single-center, randomized, crossover, prospective, clinical and double-blind study
      (the rTMS session is performed by the neurophysiologist, but the patient and the neurologist
      who will perform the handwriting evaluation are blind to the session).
    


Study Type

Interventional


Primary Outcome

immediate and significant improvement in writing

Secondary Outcome

 significant improvement in writing

Condition

Wilson Disease

Intervention

Repetitive Transcranial Magnetic Stimulation (rTMS)

Study Arms / Comparison Groups

 Active rTMS
Description:  Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

15

Start Date

January 2014

Completion Date

February 2016

Primary Completion Date

February 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Wilson disease with focal right hand dystonia

          -  No modification of medical treatment for 6 months

          -  No botulinum toxin administration within the past four months

          -  Right handed

          -  Focal right hand dystonia

          -  Cerebral Magnetic Resonance performed the last 6 months with no other lesion than met
             in Wilson disease

          -  Over 18

          -  Insurance policy holder

          -  Informed consent

        Exclusion Criteria:

          -  Pregnant woman

          -  Guardianship procedure

          -  Seizure history

          -  Other cerebral lesions on cerebral MRI than met in Wilson Disease

          -  Unable to stay quiet for 30 minutes

          -  Handwriting impossible

          -  Contra-indications to repetitive Transcranial Magnetic Stimulation
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nathalie KUBIS, MD, PhD, 33 1 49 95 83 14/80 88, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT01980433

Organization ID

P121105


Responsible Party

Sponsor

Study Sponsor

Assistance Publique - Hôpitaux de Paris


Study Sponsor

Nathalie KUBIS, MD, PhD, Study Director, Physiology Department, Lariboisière Hospital


Verification Date

May 2015