Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia (STAC2)

March 27, 2017 updated by: Fondation Ophtalmologique Adolphe de Rothschild
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • France
      • Paris, France, 75019
        • Fondation ophtalmique Adolphe de Rothschild

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

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • 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

No Inclusion Criteria:

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

For patients, are added the following no inclusion criteria are added:

  • Trembling cervical dystonia
  • Injection of botulinum toxin in the past three months

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patients with cervical dystonia
Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia
Device: Electromyogram
Other: patients without cervical dystonia
Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia
Device: Electromyogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
Time Frame: two hours
two hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2015

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 13, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 27, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSA_2014_23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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