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Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia (LICIdystonie)

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ClinicalTrials.gov Identifier: NCT03381456
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dystonia, Primary Other: LICI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 10 patient with dystonia and 10 healthy subject paired by sex and age.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Study Start Date : April 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Healthy subject
LICI
 Other: LICI
Paired pulse TMS to measure LICI and late cortical disinhibition
Experimental: Dystonic subject
LICI
 Other: LICI
Paired pulse TMS to measure LICI and late cortical disinhibition


Outcome Measures
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Primary Outcome Measures :
  1. long-interval intracortical inhibition (LICI) level [ Time Frame: Baseline ]
    Amount of inhibition at interstimulus intervals of between 50 to 300ms


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381456


Locations
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France
Hôpital Roger Salengro, CHRU de Lille
Lille, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Philippe Derambure, MD, PhD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03381456    
Other Study ID Numbers: 2013_51
2014-A00244-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
 Nervous System Diseases
Movement Disorders
Central Nervous System Diseases