Writer's CrampIWCToxinNCT03085745
Sensorimotor Mapping in Patients With Writer's Cramp
A study testing Transcranial Magnetic Stimulation (TMS) in people with Writer's Cramp, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Writer's Cramp
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2017to 19 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
anais adolle contact
France1 site, 1 recruiting
- Recruiting
Grenoble University Hospital
Grenoble, 38300
Estelle Raffin, PhD, 456520688 ext. +33, estelle.raffin@univ-grenoble-alpes.fr
elena moro, md phd
About this study
Official title: Corticomotor Plasticity as a Biomarker for Functional Improvement After Botulinium Treatment in Writer's Cramp
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.
Read the 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
- Being tested
- Transcranial Magnetic Stimulation (TMS)
- Keywords
- Writer's cramp, Sensorimotor plasticity, TMS, Afferent inhibition, Motor mapping, Sensory mapping, adaptive sensorimotor synergies, fine motor control
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic Stimulation (TMS)Other
TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This measure will be performed before the injection of botulinum toxin and 7 days after, 30 days after and 3 months after the injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start20 Feb 2017
- Primary completion19 Feb 2019 (estimated)
- Study completion19 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Writer's CrampStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena MORO, Pr, Principal investigator, amoro@chu-grenoble.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085745
- Sponsor's protocol ID
- IWCToxin
- Acronym
- IWCToxin
- Status last verified
- Jun 2018
- First submitted
- 24 Feb 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticomotor Plasticity as a Biomarker for Functional Improvement After Botulinium Treatment in Writer's Cramp
- ClinicalTrials.gov ID
- NCT03085745
- Acronym / sponsor ID
- IWCToxin / IWCToxin
- Conditions
- Writer's Cramp
- Keywords
- Writer's cramp, Sensorimotor plasticity, TMS, Afferent inhibition, Motor mapping, Sensory mapping, adaptive sensorimotor synergies, fine motor control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 19 Feb 2019 (estimated)
- Study completion
- 19 May 2019 (estimated)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Other: 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 |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS)TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles. | Other | Transcranial Magnetic Stimulation (TMS) |
Primary outcome
Corticospinal excitability profiles of intrinsic 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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Writer's Cramp
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VTS Sensorimotor Neuromodulation in WC
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Brain Networks in Dystonia
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Video-supervised Motor and Awareness Training in Writer's Cramp
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
anais adolle contact
Elena MORO, Pr principal investigator
amoro@chu-grenoble.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Writer's Cramp, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Estelle Raffin (456520688 ext. +33, estelle.raffin@univ-grenoble-alpes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corticospinal excitability profiles of intrinsic 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.