Clinical trial NCT01980433: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wilson Disease
Movement Disorders
Repetitive Transcranial Magnetic Stimulation
Keywords: Wilson disease
Dystonia
Movement Disorders
Handwriting
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-11-11
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 (\<or=1Hz) repetitive transcranial magnetic stimulation (rTMS) has shown inhibiting properties when applied over the cortex. Since dystonia has been correlated to hyperactivation of the neurons of the somatosensory cortex (SSC), we hypothesize that one single 20-minute session of 1 Hz rTMS applied on left SSC will improve writing of the right dystonic hand, assessed immediately at the end of the session.

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).

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

Primary outcomes:
measure: immediate and significant improvement in writing
timeFrame: up to 1 week
Secondary outcomes:
measure: significant improvement in writing
timeFrame: up to 1 week
measure: improvement of dystonia on the scale WDRS
timeFrame: up to 1 week
measure: correlation between the scores and the other parameters of disease severity
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Lariboisiere
state: Ile De France
Study officials:
affiliation: Physiology Department, Lariboisière Hospital
name: Nathalie KUBIS, MD, PhD
role: STUDY_DIRECTOR
affiliation: Neurology, Lariboisière Hospital
name: Jean-Marc TROCELLO, MD
role: PRINCIPAL_INVESTIGATOR
References: