Inhibitory rTMS in Dystonic Wilson Patients

Movement Disorders Clinical Trial

— WILSTIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01980433
• Other study ID #: P121105
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: July 2015

Study information

• Verified date: June 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Repetitive Transcranial Magnetic Stimulation
• Wilson Disease

Intervention

Device:
• Repetitive Transcranial Magnetic Stimulation (rTMS)
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.

Other:
• pre and post-rTMS electroencephalogram
to verify the absence of infraclinical seizures
• WCRS
Writer's cramp rating scale
• handwriting scale DPRE
handwriting in development and being evaluated by the NRC Wilson
• visual analog scale of discomfort writing and parameters collected on touchpad

Locations

Country	Name	City	State
France	Hospital Lariboisiere	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	immediate and significant improvement in writing	Improvement of handwriting performance immediately after one single 20 minutes session of inhibitory (1 Hz) repetitive transcranial magnetic stimulation over the left somatosensory cortex.; quantitative test score of writing WCRS; Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.	up to 1 week
Secondary	significant improvement in writing	improvement of other quantitative test scores of writing (VAS subjective discomfort writing, DPRE scales and parameters measured on touchpad) after a single session of 1 Hz rTMS inhibitory to the left CSS , compared to the scores achieved in the 24 hours before the session of rTMS.; Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.	up to 1 week
Secondary	improvement of dystonia on the scale WDRS	Assessing the improvement of dystonia on the scale WDRS after a single session of 1 Hz rTMS inhibitory to the left CSS, compared to the scores achieved in the 24 hours before the session of rTMS.; Active or sham stimulation will be randomly assigned to the patient and the other session will be performed 3 days later.	up to 1 week
Secondary	correlation between the scores and the other parameters of disease severity	Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.	up to 1 week