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Agency in Dystonia (AGENT10)

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ClinicalTrials.gov Identifier: NCT03351218
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : November 22, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

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.


Condition or disease Intervention/treatment Phase
Dystonia, Primary Behavioral: Behavioral testing - computerized tasks Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Official Title: Neuronal Correlates of Agency in Dystonia
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : October 23, 2019
Estimated Study Completion Date : December 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arm Intervention/treatment
Patients
25 patients with cervical and 25 patients with myoclonus dystonia
Behavioral: Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI

Controls
50 healthy volunteers matched to patents ( age, sex)
Behavioral: Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI




Primary Outcome Measures :
  1. agency tasks behavioral outcome measures [ Time Frame: throughout study completion, an average 2 years ]
    response time

  2. agency tasks behavioral outcome measures [ Time Frame: throughout study completion, an average 2 years ]
    response accuracy in tasks trials


Secondary Outcome Measures :
  1. MRI measures [ Time Frame: throughout study completion, an average 2 years ]
    cortical thickness

  2. MRI measures [ Time Frame: throughout study completion, an average 2 years ]
    basal ganglia volume



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Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351218


Locations
France
Centre d'investigation Clinique Recruiting
Paris, Ile De France, France, 75013
Contact: Worbe Yulia, MD, PhD    + 33 142161316    yulia.worbe@aphp.fr   
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03351218     History of Changes
Other Study ID Numbers: C17-04
2017-A01231-52 ( Registry Identifier: RCB )
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: November 22, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases