Inhibitory rTMS in Dystonic Wilson Patients

NCT01980433 | Completed

• 1 other identifier: P121105
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wilson Disease; Movement Disorders; Repetitive Transcranial Magnetic Stimulation

Keywords

Wilson disease; Dystonia; Movement Disorders; Handwriting; Repetitive Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• immediate and significant improvement in writing

  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

Secondary Outcomes (3)

• significant improvement in writing

  up to 1 week

• improvement of dystonia on the scale WDRS

  up to 1 week

• correlation between the scores and the other parameters of disease severity

  up to 1 week

Study Arms (2)

Active rTMS

EXPERIMENTAL

Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Other: pre and post-rTMS electroencephalogram; Other: WCRS; Other: handwriting scale DPRE; Other: visual analog scale of discomfort writing and parameters collected on touchpad

Sham rTMS

SHAM COMPARATOR

Placebo Transcranial Magnetic stimulation delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.

Device: Repetitive Transcranial Magnetic Stimulation (rTMS); Other: pre and post-rTMS electroencephalogram; Other: WCRS; Other: handwriting scale DPRE; Other: visual analog scale of discomfort writing and parameters collected on touchpad

Interventions

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.

Active rTMS; Sham rTMS

pre and post-rTMS electroencephalogram OTHER

to verify the absence of infraclinical seizures

Active rTMS; Sham rTMS

WCRS OTHER

Writer's cramp rating scale

Active rTMS; Sham rTMS

handwriting scale DPRE OTHER

handwriting in development and being evaluated by the NRC Wilson

Active rTMS; Sham rTMS

visual analog scale of discomfort writing and parameters collected on touchpad OTHER

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Lariboisiere

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

Location

MeSH Terms

Conditions

Hepatolenticular Degeneration; Movement Disorders; Dystonia

Interventions

Transcranial Magnetic Stimulation; Lead

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolism, Inborn Errors; Metal Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Nathalie KUBIS, MD, PhD

  Physiology Department, Lariboisière Hospital

  STUDY DIRECTOR

• Jean-Marc TROCELLO, MD

  Neurology, Lariboisière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 11, 2013
• Study Start: January 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 15, 2021

Record last verified: 2021-06

Locations

FR (1)