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
14
Start Date
January 2014
Completion Date
July 2015
Primary Completion Date
July 2015
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, ,
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
June 2021