NCT02834871

Brief Summary

The purpose of this study is to compare the cervical muscular force control , taking into account the proprioceptive signals, in patients with and without cervical dystonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

July 13, 2016

Last Update Submit

March 27, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition

    two hours

Study Arms (2)

patients with cervical dystonia

OTHER

Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia

Device: Electromyogram

patients without cervical dystonia

OTHER

Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia

Device: Electromyogram

Interventions

patients with cervical dystoniapatients without cervical dystonia

Eligibility Criteria

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

You may qualify if:

  • patients presenting focal or segmental cervical dystonia diagnosed by a neurologist expert in the diseases with abnormal movements
  • having signed a consent for study participation
  • Neurological affection other than cervical dystonia (typical or atypical parkinsonism, other ...)
  • Severe pain, trauma or disease of the cervical spine known or suspected other than cervical dystonia requiring treatment in the last 6 months
  • Ongoing neuroleptic treatment
  • Pregnancy or breastfeeding
  • Lack of insurance coverage
  • Trembling cervical dystonia
  • Injection of botulinum toxin in the past three months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmique Adolphe de Rothschild

Paris, Paris, 75019, France

Location

Related Publications (1)

  • Carment L, Maier MA, Sangla S, Guiraud V, Mesure S, Vidailhet M, Lindberg PG, Bleton JP. Does dystonic muscle activity affect sense of effort in cervical dystonia? PLoS One. 2017 Feb 13;12(2):e0172019. doi: 10.1371/journal.pone.0172019. eCollection 2017.

MeSH Terms

Conditions

Torticollis

Interventions

Electromyography

Condition Hierarchy (Ancestors)

DystoniaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ElectrodiagnosisDiagnostic Techniques and ProceduresDiagnosisMyography

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations