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

Primary Purpose

Dystonia, Primary

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
LICI
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dystonia, Primary

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Hôpital Roger Salengro, CHRU de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy subject

Dystonic subject

Arm Description

LICI

LICI

Outcomes

Primary Outcome Measures

long-interval intracortical inhibition (LICI) level
Amount of inhibition at interstimulus intervals of between 50 to 300ms

Secondary Outcome Measures

Full Information

First Posted
December 18, 2017
Last Updated
December 18, 2017
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03381456
Brief Title
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Acronym
LICIdystonie
Official Title
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystonia, Primary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 patient with dystonia and 10 healthy subject paired by sex and age.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy subject
Arm Type
Experimental
Arm Description
LICI
Arm Title
Dystonic subject
Arm Type
Experimental
Arm Description
LICI
Intervention Type
Other
Intervention Name(s)
LICI
Intervention Description
Paired pulse TMS to measure LICI and late cortical disinhibition
Primary Outcome Measure Information:
Title
long-interval intracortical inhibition (LICI) level
Description
Amount of inhibition at interstimulus intervals of between 50 to 300ms
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Derambure, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHRU de Lille
City
Lille
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

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