Inhibitory rTMS in Dystonic Wilson Patients

NCT ID: NCT01980433

Last Updated: 2021-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

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).

Conditions

Wilson Disease; Movement Disorders; Repetitive Transcranial Magnetic Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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

Intervention Type: OTHER

to verify the absence of infraclinical seizures

WCRS

Intervention Type: OTHER

Writer's cramp rating scale

handwriting scale DPRE

Intervention Type: OTHER

handwriting in development and being evaluated by the NRC Wilson

visual analog scale of discomfort writing and parameters collected on touchpad

Intervention Type: OTHER

Sham rTMS

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

Group Type: SHAM_COMPARATOR

Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: 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

Intervention Type: OTHER

to verify the absence of infraclinical seizures

WCRS

Intervention Type: OTHER

Writer's cramp rating scale

handwriting scale DPRE

Intervention Type: OTHER

handwriting in development and being evaluated by the NRC Wilson

visual analog scale of discomfort writing and parameters collected on touchpad

Intervention Type: OTHER

Interventions

Repetitive Transcranial Magnetic Stimulation (rTMS)

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

Intervention Type: DEVICE

pre and post-rTMS electroencephalogram

to verify the absence of infraclinical seizures

Intervention Type: OTHER

WCRS

Writer's cramp rating scale

Intervention Type: OTHER

handwriting scale DPRE

handwriting in development and being evaluated by the NRC Wilson

Intervention Type: OTHER

visual analog scale of discomfort writing and parameters collected on touchpad

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathalie KUBIS, MD, PhD

Role: STUDY_DIRECTOR

Physiology Department, Lariboisière Hospital

Jean-Marc TROCELLO, MD

Role: PRINCIPAL_INVESTIGATOR

Neurology, Lariboisière Hospital

Locations

Hospital Lariboisiere

Paris, Île-de-France Region, France

Countries

France

Other Identifiers

P121105

Identifier Type: -

Identifier Source: org_study_id