Back to resultsIntegration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia (STAC2)
Primary Purpose
Cervical Dystonia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electromyogram
Sponsored by
About this trial
This is an interventional basic science trial for Cervical Dystonia
Eligibility Criteria
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
Sites / Locations
- Fondation Ophtalmique Adolphe de Rothschild
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
patients with cervical dystonia
patients without cervical dystonia
Arm Description
Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia
Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia
Outcomes
Primary Outcome Measures
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
Secondary Outcome Measures
Full Information
NCT ID
NCT02834871
First Posted
July 13, 2016
Last Updated
March 27, 2017
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT02834871
Brief Title
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
Acronym
STAC2
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Dystonia
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients with cervical dystonia
Arm Type
Other
Arm Description
Computerized assessment of the cervical muscular force and with electromyogram in patients with cervical dystonia
Arm Title
patients without cervical dystonia
Arm Type
Other
Arm Description
Computerized assessment of the cervical muscular force and with electromyogram in patients without cervical dystonia
Intervention Type
Device
Intervention Name(s)
Electromyogram
Primary Outcome Measure Information:
Title
Measuring (in Newton) of the muscular force exerted by extending movements of the cervical spine in static and dynamic condition
Time Frame
two hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation Ophtalmique Adolphe de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
28192488
Citation
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.
Results Reference
result
Learn more about this trial
Integration of the Cervical Proprioceptive Signals in Patients With Cervical Dystonia
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