Sensorimotor Mapping in Patients With Writer's Cramp (IWCToxin)
Primary Purpose
Writer's Cramp
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
About this trial
This is an interventional basic science trial for Writer's Cramp focused on measuring Writer's cramp, Sensorimotor plasticity, TMS, Afferent inhibition, Motor mapping, Sensory mapping, adaptive sensorimotor synergies, fine motor control
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.
Sites / Locations
- Grenoble University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcranial Magnetic Stimulation (TMS)
Arm Description
15 patients suffering from a writer's cramp, aged 20-80 who are currently treated with botulinum toxin will receive single pulse TMS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03085745
First Posted
February 24, 2017
Last Updated
June 1, 2018
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT03085745
Brief Title
Sensorimotor Mapping in Patients With Writer's Cramp
Acronym
IWCToxin
Official Title
Corticomotor Plasticity as a Biomarker for Functional Improvement After Botulinium Treatment in Writer's Cramp
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
February 19, 2019 (Anticipated)
Study Completion Date
May 19, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Writer's Cramp
Keywords
Writer's cramp, Sensorimotor plasticity, TMS, Afferent inhibition, Motor mapping, Sensory mapping, adaptive sensorimotor synergies, fine motor control
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transcranial Magnetic Stimulation (TMS)
Arm Type
Experimental
Arm Description
15 patients suffering from a writer's cramp, aged 20-80 who are currently treated with botulinum toxin will receive single pulse TMS
Intervention Type
Other
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles.
Primary Outcome Measure Information:
Title
Corticospinal excitability profiles of intrinsic hand muscles
Description
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.
Time Frame
This measure will be performed before the injection of botulinum toxin and 7 days after, 30 days after and 3 months after the injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Estelle Raffin
Phone
456520688
Ext
+33
Email
estelle.raffin@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
anais adolle
Email
aadolle@chu-grenoble.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena MORO, Pr
Organizational Affiliation
amoro@chu-grenoble.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble University Hospital
City
Grenoble
ZIP/Postal Code
38300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estelle Raffin, PhD
Phone
456520688
Ext
+33
Email
estelle.raffin@univ-grenoble-alpes.fr
First Name & Middle Initial & Last Name & Degree
elena moro, md phd
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Sensorimotor Mapping in Patients With Writer's Cramp
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