rTMS in Wilson Disease Dysarthria

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

A consecutive series of Wilson disease patients with dystonic hyperkinetic dysarthria will be prospectively recruited. Patients will receive 3 days apart to two rTMS sessions. rTMS procedures will be performed with a figure of eight coiled. A single 20-minutes 1 Hz biphasic stimulation (1200 pulses) session will be applied over the laryngeal motor cortex. A brain imaging positioning device will be used during all the procedure A second stimulation session will be performed 3 days apart. Patients will be centrally randomized to receive first either the active stimulation (80% of the resting motor threshold) or the sham stimulation (using a visually identical coil to reproduce the click sound and the scalp sensation of the active coil). A TMS evaluation of cortical silent period over the left motor cortex will be performed before the first rTMS session. Before and immediately after each stimulation (active or sham) patient will received an clinical evaluation including Clinical Assessment Battery for Dysarthria intelligibility score, "A" phonation time, diadococinesia , bucco-linguo-facial motricity score and UWDRS. A standard 20-minutes EEG will be performed before the first rTMS session and immediately after the second rTMS session. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04910581
Study type	Interventional
Source	Assistance Publique - Hôpitaux de Paris
Contact
Status	Completed
Phase	N/A
Start date	January 23, 2023
Completion date	January 12, 2024

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See also
Status	Clinical Trial	Phase
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Active, not recruiting	`NCT04884815` - Study of UX701 Gene Transfer for the Treatment of Wilson Disease	Phase 1/Phase 2
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Completed	`NCT04965571` - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated	`NCT05047523` - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease	Phase 3
Completed	`NCT04526210` - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants	Phase 1
Completed	`NCT00004338` - Study of Zinc for Wilson Disease	Phase 4
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Completed	`NCT02273596` - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients	Phase 2
Completed	`NCT02763215` - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting	`NCT05444127` - Oral Health and Wilson's Disease: SOMAWI
Completed	`NCT04408300` - Study of Retinal Vascular Parameters in Patients With Wilson's Disease	N/A
Recruiting	`NCT05783687` - Real World Evidence Study in Subjects With Wilson's Disease
Terminated	`NCT04909346` - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed	`NCT03867526` - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation	`NCT03589820` - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure	N/A
Completed	`NCT04526197` - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.	Phase 1
Active, not recruiting	`NCT02426905` - Study to Assess Long-Term Outcomes of Trientine in Wilson Disease Patients Withdrawn From Therapy With d-Penicillamine	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

rTMS in Wilson Disease Dysarthria — WILSTIM2

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms