An interventional study of rTMS and Sham stimulation in Wilson Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 17 studies in Hepatolenticular Degeneration with a site in France — 8 open to participants now, 8 under way, none of them phase 3. Hepatolenticular Degeneration · France.
Among the 17 studies in Hepatolenticular Degeneration with a site in France, this one is the 8th largest by enrollment of the 11 interventional ones that give a count, is one of 3 that started in 2023, is one of 8 with no phase, and was the 6th registered.
80 studies on the registry are indexed under Hepatolenticular Degeneration; 31 are open to participants now.
Browse Hepatolenticular Degeneration studies →8 of the 17 studies in Hepatolenticular Degeneration with a site in France are open now. Recruiting first, the newest first:
Fondation Ophtalmologique Adolphe de Rothschild · Sites in France
Ages 7+
Centre Hospitalier Universitaire de Saint Etienne · Sites in France
Ages 12+ · Healthy volunteers
Hospices Civils de Lyon · Sites in France
Ages 6–70
Fondation Ophtalmologique Adolphe de Rothschild · Sites in France
Ages 18+ · Healthy volunteers
Fondation Ophtalmologique Adolphe de Rothschild · Sites in France
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 21 Hepatolenticular Degeneration studies recruiting now, 16 (76%) set no upper age limit and 4 (19%) stop at 75 or younger; 14 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 3 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 18 is below the median of 30 across 44 interventional studies indexed under Hepatolenticular Degeneration.
Median enrollment 40 across the 11 interventional studies, 150 across the 6 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
5 of 17 have an industry lead sponsor. The 7 most frequent:
Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
Assistance Publique - Hôpitaux de Paris has 2 studies filed under Hepatolenticular Degeneration — fewer than ten, so there is no comparison to draw.
3 of the studies in Hepatolenticular Degeneration with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06430359Hospices Civils de LyonCircadian Variation of Urinary Copper Excretion in Wilson Disease Patients | 2027-02-10 |
| NCT05183165Fondation Ophtalmologique Adolphe de RothschildDescription of the Copper Concentration in Breast Milk in Women Treated for Wilson's Disease | 2027-03 |
| NCT05444127Fondation Ophtalmologique Adolphe de RothschildOral Health and Wilson's Disease: SOMAWI | 2027-08 |
Add all 3 to your calendar (.ics) → With an account.
Among the 17 studies in Hepatolenticular Degeneration with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receive an inhibitor treatment of rTMS using activ coil (MCF B65 coil) for 30 minutes at 1Hz at 80% of the resting motor threshold (MagPro stimulator; MagVenture A / S, Farum, Denmark) onto the left laryngeal cortex located thanks to a neuronavigation device (Syneika one \[SYN1\], Syneika, Cesson-Sévigné, France).
Procedure: rTMS
Patients receive a treatment of rTMS using placebo coil (MCF P B65 coil) for 30 minutes at 1Hz (MagPro stimulator; MagVenture A / S, Farum, Denmark) onto the left laryngeal cortex located thanks to a neuronavigation device (Syneika one \[SYN1\], Syneika, Cesson-Sévigné, France).
Procedure: Sham stimulation
Single 30-minutes session of 1Hz rTMS applied over the left laryngeal motor cortex
Single 30-minutes session of sham stimulation applied over the left laryngeal motor cortex
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
Time frame: within 30 minutes after stimulation session at Day1 and Day4
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
Time frame: within 30 minutes after stimulation session at Day1 and Day4
the "A" phonation time
Improvement of the "A" phonation time with active stimulation in comparison to sham stimulation
Time frame: within 30 minutes after stimulation session at Day1 and Day4
Improvement of the diadococinesia
Improvement of the diadococinesia with active stimulation in comparison to sham stimulation
Time frame: within 30 minutes after stimulation session at Day1 and Day4
Improvement of text reading
Improvement of text reading with active stimulation in comparison to sham stimulation
Time frame: within 30 minutes after stimulation session at Day1 and Day4
Improvement of bucco-linguo-facial motricity
Improvement of bucco-linguo-facial motricity with active stimulation in comparison to sham stimulation
Time frame: within 30 minutes after stimulation session at Day1 and Day4
Improvement bucco-linguo-facial motricity
Improvement bucco-linguo-facial motricity with active stimulation in comparison to sham stimulation
Time frame: within 30 minutes after stimulation session at Day1 and Day4
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)
Time frame: at Day1 and Day4
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.
Time frame: within few hours after stimulation session at Day1 and Day4
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2023 to primary completion in Jan 2024, 11 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hepatolenticular Degeneration →
Assistance Publique - Hôpitaux de Paris →