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Trial record 1 of 2 for:    agent10
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Agency in Dystonia (AGENT10)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03351218
Recruitment Status : Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : November 29, 2021
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE October 10, 2017
First Posted Date  ICMJE November 22, 2017
Last Update Posted Date November 29, 2021
Actual Study Start Date  ICMJE October 23, 2017
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • agency tasks behavioral outcome measures [ Time Frame: throughout study completion, an average 2 years ]
    response time
  • agency tasks behavioral outcome measures [ Time Frame: throughout study completion, an average 2 years ]
    response accuracy in tasks trials
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • MRI measures [ Time Frame: throughout study completion, an average 2 years ]
    cortical thickness
  • MRI measures [ Time Frame: throughout study completion, an average 2 years ]
    basal ganglia volume
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Agency in Dystonia
Official Title  ICMJE Neuronal Correlates of Agency in Dystonia
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)

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups study : patients versus healthy controls
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Dystonia, Primary
Intervention  ICMJE Behavioral: Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI
Study Arms  ICMJE
  • Patients
    25 patients with cervical and 25 patients with myoclonus dystonia
    Intervention: Behavioral: Behavioral testing - computerized tasks
  • Controls
    50 healthy volunteers matched to patents ( age, sex)
    Intervention: Behavioral: Behavioral testing - computerized tasks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2021)
113
Original Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
100
Estimated Study Completion Date  ICMJE October 15, 2022
Estimated Primary Completion Date October 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03351218
Other Study ID Numbers  ICMJE C17-04
2017-A01231-52 ( Registry Identifier: RCB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP