Skip to main content
OpenTrials
Completed

NCT Number: NCT01980433

Inhibitory rTMS in Dystonic Wilson Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Wilson Disease Basal Ganglia Diseases Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Dyskinesias Dystonia Genetic Diseases, Inborn Hepatolenticular Degeneration Heredodegenerative Disorders, Nervous System Liver Diseases Metabolic Diseases Metabolism, Inborn Errors Metal Metabolism, Inborn Errors Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Repetitive Transcranial Magnetic Stimulation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Lariboisiere

Paris, Île-de-France Region, 75010, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Repetitive transcranial magnetic stimulation (rTMS)

Device

Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.

pre and post-rTMS electroencephalogram

Other

to verify the absence of infraclinical seizures

WCRS

Other

Writer's cramp rating scale

handwriting scale DPRE

Other

handwriting in development and being evaluated by the NRC Wilson

visual analog scale of discomfort writing and parameters collected on touchpad

Other

Primary outcomes

  1. immediate and significant improvement in writing

    Time frame: 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.

Secondary outcomes

  1. significant improvement in writing

    Time frame: 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.

  2. improvement of dystonia on the scale WDRS

    Time frame: 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.

  3. correlation between the scores and the other parameters of disease severity

    Time frame: up to 1 week

    Assess whether age, disease duration and the presence of cortical atrophy are inversely correlated with the evolution of scores.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: WILSTIM

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 11, 2013
Registry last updated
Jun 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.