- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03381456
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia (LICIdystonie)
December 18, 2017 updated by: University Hospital, Lille
Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS).
Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity.
In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures.
the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lille, France
- Hopital Roger Salengro, CHRU de Lille
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient with hand dystonia : writers cramp
- Subject affiliated to social security regimen.
For healthy volunteers :
- Healthy volunteer without neurological disorders based on sensorimotor examination.
- Subject affiliated to social security regimen.
Exclusion Criteria :
- Subject unable to receive informed consent (dementia).
- Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant).
- Patient using a psychotrope treatment.
- Patient under guardianship or curatorship.
- Pregnant or nursing women.
- Patient with a cardiac stimulator.
For healthy volunteers only :
• Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Healthy subject
LICI
|
Paired pulse TMS to measure LICI and late cortical disinhibition
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EXPERIMENTAL: Dystonic subject
LICI
|
Paired pulse TMS to measure LICI and late cortical disinhibition
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
long-interval intracortical inhibition (LICI) level
Time Frame: Baseline
|
Amount of inhibition at interstimulus intervals of between 50 to 300ms
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (ACTUAL)
April 1, 2017
Study Completion (ACTUAL)
April 1, 2017
Study Registration Dates
First Submitted
December 18, 2017
First Submitted That Met QC Criteria
December 18, 2017
First Posted (ACTUAL)
December 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 18, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013_51
- 2014-A00244-43 (OTHER: ID-RCB number, ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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