Agency in Dystonia (AGENT10)

November 25, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Neuronal Correlates of Agency in Dystonia

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

113

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
    • Ile De France
      • Paris, Ile De France, France, 75013
        • Centre d'Investigation Clinique

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

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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
25 patients with cervical and 25 patients with myoclonus dystonia
Behavioral: Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI
Other: Controls
50 healthy volunteers matched to patents ( age, sex)
Behavioral: Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
agency tasks behavioral outcome measures
Time Frame: throughout study completion, an average 2 years
response time
throughout study completion, an average 2 years
agency tasks behavioral outcome measures
Time Frame: throughout study completion, an average 2 years
response accuracy in tasks trials
throughout study completion, an average 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI measures
Time Frame: throughout study completion, an average 2 years
cortical thickness
throughout study completion, an average 2 years
MRI measures
Time Frame: throughout study completion, an average 2 years
basal ganglia volume
throughout study completion, an average 2 years

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

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)

October 23, 2017

Primary Completion (Anticipated)

October 15, 2022

Study Completion (Anticipated)

October 15, 2022

Study Registration Dates

First Submitted

October 10, 2017

First Submitted That Met QC Criteria

November 21, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 29, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C17-04
  • 2017-A01231-52 (Registry Identifier: RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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