AGENT10: Agency in Dystonia

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03351218
• Collaborator: (none)
• Enrollment: 113
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 59.7
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dystonia, Primary	Behavioral: Behavioral testing - computerized tasks	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 113 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Two groups study : patients versus healthy controlsTwo 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: Oct 23, 2017
• Anticipated Primary Completion Date: Oct 15, 2022
• Anticipated Study Completion Date: Oct 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. agency tasks behavioral outcome measures [throughout study completion, an average 2 years]

   response time

2. agency tasks behavioral outcome measures [throughout study completion, an average 2 years]

   response accuracy in tasks trials

Secondary Outcome Measures

1. MRI measures [throughout study completion, an average 2 years]

   cortical thickness

2. MRI measures [throughout study completion, an average 2 years]

   basal ganglia volume

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'investigation Clinique	Paris	Ile De France	France	75013

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT03351218
• Other Study ID Numbers: C17-04; 2017-A01231-52
• First Posted: Nov 22, 2017
• Last Update Posted: Nov 29, 2021
• Last Verified: Nov 1, 2021

• 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

Study Results

No Results Posted as of Nov 29, 2021