Agency in Dystonia

Dystonia, Primary Clinical Trial

— AGENT10  

Official title:

Neuronal Correlates of Agency in Dystonia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03351218
• Other study ID #: C17-04
• Secondary ID: 2017-A01231-52
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: October 15, 2022

Study information

• Verified date: November 2021
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 113
• Est. completion date: October 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonia, Primary
• Dystonic Disorders

Intervention

Behavioral:
• Behavioral testing - computerized tasks
Cognitive behavioral testing and cerebral MRI

Locations

Country	Name	City	State
France	Centre d'investigation Clinique	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	agency tasks behavioral outcome measures	response time	throughout study completion, an average 2 years
Primary	agency tasks behavioral outcome measures	response accuracy in tasks trials	throughout study completion, an average 2 years
Secondary	MRI measures	cortical thickness	throughout study completion, an average 2 years
Secondary	MRI measures	basal ganglia volume	throughout study completion, an average 2 years