Agency in Dystonia (AGENT10)

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

Status: Completed

Conditions: Dystonia, Primary

Treatments: Behavioral: Behavioral testing - computerized tasks

Study type: Interventional

Funder types: Other

Identifiers

NCT03351218

2017-A01231-52 (Registry Identifier)

C17-04

Details and patient eligibility

About

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.

Full 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)

Enrollment: 76 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Patients

Other group

Description:

25 patients with cervical and 25 patients with myoclonus dystonia

Treatment:

Behavioral: Behavioral testing - computerized tasks

Controls

Other group

Description:

50 healthy volunteers matched to patents ( age, sex)

Treatment:

Behavioral: Behavioral testing - computerized tasks