Inhibitory rTMS in Dystonic Wilson Patients (WILSTIM)
Study of Writing Improvement in Patients With Wilson Disease and Dystonia After One Session of Inhibitory Repetitive Transcranial Magnetic Stimulation
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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).
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Ile De France
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Paris, Ile De France, France, 75010
- Hospital Lariboisière
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Active rTMS
Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
|
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
to verify the absence of infraclinical seizures
Writer's cramp rating scale
handwriting in development and being evaluated by the NRC Wilson
|
|
Comparateur factice: Sham rTMS
Placebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
|
Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest.
Intervention is delivered during 20 minutes in one single session.
to verify the absence of infraclinical seizures
Writer's cramp rating scale
handwriting in development and being evaluated by the NRC Wilson
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
immediate and significant improvement in writing
Délai: up to 1 week
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
significant improvement in writing
Délai: up to 1 week
|
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
|
|
improvement of dystonia on the scale WDRS
Délai: up to 1 week
|
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
|
|
correlation between the scores and the other parameters of disease severity
Délai: up to 1 week
|
Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.
|
up to 1 week
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Nathalie KUBIS, MD, PhD, Physiology Department, Lariboisière Hospital
- Chercheur principal: Jean-Marc TROCELLO, MD, Neurology, Lariboisière Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Maladies métaboliques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies du foie
- Maladies génétiques, innées
- Maladies des noyaux gris centraux
- Maladies neurodégénératives
- Métabolisme, erreurs innées
- Troubles hérédodégénératifs, système nerveux
- Maladies cérébrales métaboliques
- Maladies cérébrales, métaboliques, innées
- Métabolisme des métaux, erreurs innées
- Troubles du mouvement
- Dégénérescence hépatolenticulaire
Autres numéros d'identification d'étude
- P121105
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