NCT03085745

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2017

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2017

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 19, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2019

Completed
Last Updated

June 4, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

February 24, 2017

Last Update Submit

June 1, 2018

Conditions

Writer's Cramp

Keywords

Writer's crampSensorimotor plasticityTMSAfferent inhibitionMotor mappingSensory mappingadaptive sensorimotor synergiesfine motor control

Outcome Measures

Primary Outcomes (1)

  • Corticospinal excitability profiles of intrinsic hand muscles

    We will use a newly developed neuronavigated and robotized Transcranial Magnetic Stimulation (TMS) mapping approach consisting in an individually adjusted stimulation grid located along the longitudinal axis of the motor cortex. It will generate a linear mediolateral excitability profile for each hand muscle based on the mean Motor Evoked Potentials (MEPs) amplitude at each stimulation site, on both hemispheres. Changes in excitability profiles will reflect spatial reorganization of cortical motor output maps of the hand muscles.

    This measure will be performed before the injection of botulinum toxin and 7 days after, 30 days after and 3 months after the injection.

Study Arms (1)

Transcranial Magnetic Stimulation (TMS)

EXPERIMENTAL

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

Other: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS)OTHER

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

Transcranial Magnetic Stimulation (TMS)

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble University Hospital

Grenoble, 38300, France

RECRUITING

MeSH Terms

Conditions

Dystonic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Elena MORO, Pr

    amoro@chu-grenoble.fr

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Estelle Raffin

CONTACT

456520688estelle.raffin@univ-grenoble-alpes.fr

anais adolle

CONTACT

aadolle@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 21, 2017

Study Start

February 20, 2017

Primary Completion

February 19, 2019

Study Completion

May 19, 2019

Last Updated

June 4, 2018

Record last verified: 2018-06

Locations

FR(1)