NCT03381456

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

December 18, 2017

Last Update Submit

December 18, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • long-interval intracortical inhibition (LICI) level

    Amount of inhibition at interstimulus intervals of between 50 to 300ms

    Baseline

Study Arms (2)

Healthy subject

EXPERIMENTAL

LICI

Other: LICI

Dystonic subject

EXPERIMENTAL

LICI

Other: LICI

Interventions

LICIOTHER

Paired pulse TMS to measure LICI and late cortical disinhibition

Dystonic subjectHealthy subject

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Roger Salengro, CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Dystonic Disorders

Condition Hierarchy (Ancestors)

Movement DisordersCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philippe Derambure, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 10 patient with dystonia and 10 healthy subject paired by sex and age.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2017

First Posted

December 22, 2017

Study Start

April 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations