Sensorimotor Mapping in Patients With Writer's Cramp

NCT ID: NCT03085745

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2019-05-19

Brief Summary

Writer's cramp (WC) is a form of focal dystonia, a movement disorder characterized by sustained or intermittent muscle contractions causing abnormal, often repetitive movements, postures, or both. It typically manifests while writing, making handwriting impossible in the most severe cases. Treatment can be difficult, but one effective and well-tolerated treatment consists in local muscle injections with botulinum toxin. Although clinical improvement seems to be related to focal muscle chemodenervation, central plasticity changes may occur. The main aim of the study is to characterize and quantify the changes in intrinsic hand muscle cortical representations at rest and during isometric contractions of the finger muscles before and after treatment with botulinum toxin and the changes in sensorimotor integration in patients with writer's cramp.

Detailed Description

Fifteen WC patients will be enrolled in the study. A newly developed neuronavigated and robotized Transcranial Magnetic Stimulation (TMS) mapping approach will be used. It will generate a linear mediolateral excitability profile for two intrinsic hand muscle based on the mean Motor Evoked Potentials (MEPs) amplitude at each stimulation site. Changes in excitability profiles will reflect spatial reorganization of cortical motor output maps of the hand muscles. To measure afferent inhibition, the same mapping procedure will be repeated with a brief peripheral electrical stimulation prior the TMS pulse. These Short Afferent Inhibition (SAI) profiles will reflect the influence of the primary sensory cortex over the motor cortex. Finally, the stimulation grid will be translated to the primary somatosensory cortex and a paired pulse TMS paradigm will be applied just after a digital nerve stimulation. It will generate afferent signal processing profiles based on subjective perception for the index finger and the little finger. Participants will be tested before the botulinum toxin injections and at three different time points after the injections (7 days, 1 month and 3 months after). Botulinum toxin injections will be performed using ultrasound guide together with electromyography/nerve stimulation into the clinical affected hand muscles. Muscle selection for injections will be based on clinical criteria of postural deviation of the hand and fingers and responsible muscle forces. The dose will be chosen according to published clinical recommendation concerning starting dose for WC after the clinical examination, usually between 5 and 10 units of Xeomin® both for flexor and extensor hand/forearm muscles.

To precisely assess treatment efficacy, the Writer's Cramp Rating Scale (WCRS) as well as computer-based hand writing analyses and standard sensorimotor tests of hand functions (the Nine Holes Peg Test, a tapping test and a tactile spatial acuity task) will be performed before the injections and at each follow up session.

Conditions

Writer's Cramp

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Transcranial Magnetic Stimulation (TMS)

15 patients suffering from a writer's cramp, aged 20-80 who are currently treated with botulinum toxin will receive single pulse TMS

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation (TMS)

Intervention Type: OTHER

TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles.

Interventions

Transcranial Magnetic Stimulation (TMS)

TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Suffering from a writer's cramp
• aged 30-80 years old
• Botulinum toxin injection performed in clinical routine for their disease
• Affiliated to a social security system
• Sufficient intellectual capacities to understand the tasks to perform
• Written consent obtained

Exclusion Criteria

• Impossibility to remain sitting down without pain or discomfort for at least 3 consecutive hours
• History or psychiatric or neurological disease, different from dystonia.
• Subject under judicial oversight
• Subject being within exclusion period
• Subject not reachable in case of emergency,
• Presence of one or several contraindications to TMS
• Subject covered by the following articles from the french Code de la Santé Publique: L1121-5, L1121-6, L1121-7 et L1121-8.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena MORO, Pr

Role: PRINCIPAL_INVESTIGATOR

amoro@chu-grenoble.fr

Locations

Grenoble University Hospital

Grenoble, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Estelle Raffin

Role: CONTACT

estelle.raffin@univ-grenoble-alpes.fr

456520688 ext. +33

anais adolle

Role: CONTACT

aadolle@chu-grenoble.fr

Facility Contacts

Estelle Raffin, PhD

Role: primary

estelle.raffin@univ-grenoble-alpes.fr

456520688 ext. +33

Other Identifiers

IWCToxin

Identifier Type: -

Identifier Source: org_study_id