Agency in Dystonia (AGENT10)
Primary Purpose
Dystonia, Primary
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Behavioral testing - computerized tasks
Sponsored by
About this trial
This is an interventional basic science trial for Dystonia, Primary
Eligibility Criteria
Inclusion Criteria:
- diagnosis of isolated adult-onset cervical dystonia (CD) or myoclonus dystonia (MD);
- duration of disease of more than one year
- no botulinum toxin injection for at least three months before the study
- normal or corrected-to-normal vision.
Exclusion Criteria
- any neurological history except for dystonia,
- history of dopamine antagonist treatment,
- secondary dystonia,
- dystonia in the upper limbs,
- inability to maintain gaze straight.
Sites / Locations
- Centre d'investigation Clinique
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients
Controls
Arm Description
25 patients with cervical and 25 patients with myoclonus dystonia
50 healthy volunteers matched to patents ( age, sex)
Outcomes
Primary Outcome Measures
agency tasks behavioral outcome measures
response time
agency tasks behavioral outcome measures
response accuracy in tasks trials
Secondary Outcome Measures
MRI measures
cortical thickness
MRI measures
basal ganglia volume
Full Information
NCT ID
NCT03351218
First Posted
October 10, 2017
Last Updated
November 25, 2021
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT03351218
Brief Title
Agency in Dystonia
Acronym
AGENT10
Official Title
Neuronal Correlates of Agency in Dystonia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
October 15, 2022 (Anticipated)
Study Completion Date
October 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study, using computerized cognitive assessments combined with multi-modal neuroimaging approach investigators aim to address three specific questions on patients with cervical and myoclonus dystonia:
(i) investigate various aspects of the sense of agency and relationship to the severity of dystonia symptoms, (ii) characterize the possible link between abnormalities of movement perception and alteration of sense of agency in dystonia, (iii) (identify the neuronal underpinnings of the defective sense of agency in dystonia.
Detailed Description
This is a single-centre, two-group ( dystonia and control), case-control study using behavioural and novel multimodal neuroimaging techniques to address the study aims.
The battery of the tasks will include explicit-agency tasks, a visual discrimination task on objects movement perception. The magnetic resonance acquisition protocol will include MP2RAGE structural (10 min duration), multi echo (3 echo times) multiband (MB factor 4) resting state functional neuroimaging (15 minutes duration) and multi shell diffusion imaging sequence (15 minutes duration)
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
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups study : patients versus healthy controls
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients
Arm Type
Other
Arm Description
25 patients with cervical and 25 patients with myoclonus dystonia
Arm Title
Controls
Arm Type
Other
Arm Description
50 healthy volunteers matched to patents ( age, sex)
Intervention Type
Behavioral
Intervention Name(s)
Behavioral testing - computerized tasks
Intervention Description
Cognitive behavioral testing and cerebral MRI
Primary Outcome Measure Information:
Title
agency tasks behavioral outcome measures
Description
response time
Time Frame
throughout study completion, an average 2 years
Title
agency tasks behavioral outcome measures
Description
response accuracy in tasks trials
Time Frame
throughout study completion, an average 2 years
Secondary Outcome Measure Information:
Title
MRI measures
Description
cortical thickness
Time Frame
throughout study completion, an average 2 years
Title
MRI measures
Description
basal ganglia volume
Time Frame
throughout study completion, an average 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
diagnosis of isolated adult-onset cervical dystonia (CD) or myoclonus dystonia (MD);
duration of disease of more than one year
no botulinum toxin injection for at least three months before the study
normal or corrected-to-normal vision.
Exclusion Criteria
any neurological history except for dystonia,
history of dopamine antagonist treatment,
secondary dystonia,
dystonia in the upper limbs,
inability to maintain gaze straight.
Facility Information:
Facility Name
Centre d'investigation Clinique
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75013
Country
France
12. IPD Sharing Statement
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Agency in Dystonia
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