Wilson Disease Clinical Trial
— WILSTIM2Official title:
Inhibitory rTMS Applied on Laryngeal Motor Cortex in Wilson's Disease Patients With Dysarthria
Verified date | February 2024 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Wilson disease is a hereditary hepatic and neurological disease associated with copper accumulation. Neurological symptoms are of extra-pyramidal, cerebellar and dystonic origin. Dysarthria is one of the debilitating symptoms of Wilson disease poorly responsive to pharmacological treatment. The most common form is a dystonic hyperkinetic Dysarthria. Pathophysiology of dystonia is still not elucidated. Motor cortex hyperexcitability has been demonstrated in various forms of dystonia. Furthermore, rTMS inhibitory applied over motor cortex has been shown to transitory reduce dystonic symptoms in various forms of dystonia. In the present study, we investigate the effect of a single 1Hz 20-minutes inhibitory rTMS session applied over the motor laryngeal cortex on dyasarthria is the main kinetic dysarthria has been shown to be associated with inhibition of laryngeal motor cortex in Parkinson disease.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 12, 2024 |
Est. primary completion date | January 12, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Conseting adult patients with social insurance - Wilson disease with dystonic hyperkinetic dysarthria - Stable pharmacological therapy n the last 6 monts - Brain MRI in the previous 6 months, without additional brain lesion - Patients that did not receive botulinium toxin in the previous 4 months Exclusion Criteria: - Incapacitated adult - Previous mdedical history of epilepsia - Pregnancy or breastfeeding - Brain lesion outside basal ganglia on brain MRI - Patient consider by the investigator not able to sustain an 30 minutes rTMS session without moving - Vocal chord lesion - Previous history of laryngeal surgery - rTMS contra indication |
Country | Name | City | State |
---|---|---|---|
France | Service de Neurologie, Hopital Fondation Adolphe de Rothschild | Paris | |
France | Service de Physiologie Clinique-Explorations Fonctionnelles, AP-HP, Hôpital Lariboisière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement of the Clinical Assessment Battery for Dysarthria intelligibility score | Improvement of the Clinical Assessment Battery for Dysarthria intelligibility score with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Improvement of the Clinical Assessment Battery for Dysarthria intelligibility sub-scores | Improvement of the Clinical Assessment Battery for Dysarthria intelligibility sub-scores with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | the "A" phonation time | Improvement of the "A" phonation time with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Improvement of the diadococinesia | Improvement of the diadococinesia with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Improvement of text reading | Improvement of text reading with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Improvement of bucco-linguo-facial motricity | Improvement of bucco-linguo-facial motricity with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Improvement bucco-linguo-facial motricity | Improvement bucco-linguo-facial motricity with active stimulation in comparison to sham stimulation | within 30 minutes after stimulation session at Day1 and Day4 | |
Secondary | Correlation between clinical Assessment Battery for Dysarthria intelligibility score and UWDRS, and MRI brain atrophy and basal ganglia lesions | Correlation of changes in the Battery for Dysarthria intelligibility score with clinical parameters (age at diagnosis, delay related to first symptoms, degree of neurological handicap and brain lesions observed on basline MRI (cortical atrophy and lesions of the basal ganglia) | at Day1 and Day4 | |
Secondary | Side effects of rTMS | Any side effect after stimulation (fatigue, neck pain, neck stiffness, dizziness, nausea, itching, mood disorders ..) will be collected following the stimulation.
Side effects of rTMS are rare. Most often they are minor and transient. |
within few hours after stimulation session at Day1 and Day4 |
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