EMOTION & COGNITION IN MYOCLONUS DYSTONIA (AGENT10-ECODYST) | NCT05671068

Studies
EMOTION & COGNITION IN MYOCLONUS DYSTONIA (AGENT10-ECODYST)

NCT05671068

Sponsor

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

Status

Completed

Last Update Posted

Jan 23, 2026Actual

Enrollment

47Actual

Phase

Not provided

Conditions

Myoclonus-Dystonia
DYT11

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2022-A00786-37	Other Identifier	ID RCB

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 20, 2023Actual

Primary Completion Date

Feb 19, 2024Actual

Completion Date

Feb 19, 2024Actual

First Submitted Date

Dec 16, 2022

First Submission Date that Met QC Criteria

Jan 3, 2023

First Posted Date

Jan 4, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 21, 2026

Last Update Posted Date

Jan 23, 2026Actual

Name	Class
Assistance Publique - Hôpitaux de Paris	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Background:

Myoclonus dystonia (DYT-SGCE) is characterized by myoclonus and dystonia. Such condition is associated with a high prevalence of psychiatric symptoms which are part of the phenotype. The mechanisms underlying these non-motor symptoms are still poorly understood.

Objective:

To investigate the neural correlates of cognition and emotion in DYT-SGCE.

Design:

Participants will have 1 - 2 visits at the clinical center. The total participation time is less than 24 hours.

Participants will have a medical interview and a neurological exam. They may give a urine sample before MRI.

Participants will have a short neuropsychologic and psychiatric interviews. Participants will have MRI scans. They will do small tasks or be asked to imagine things during the scanning.

Detailed Description

Eligibility:

DYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DYT-SGCE		Patients with myoclonus dystonia (DYT-SGCE)
Healthy volunteers		Control group

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
BOLD signal derived from the functional magnetic resonance imaging	Explore the differences in DYT-SGCE compared to HV	46 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

For all participants:

Age between 15-60 years
Able to give informed consent.

For patients:

An established diagnostic of DYT-SGCE
No change in medication (related to DYT-SGCE) for a month

For controls:

No neurological symptoms
No medication except oral contraception

Exclusion Criteria:

No deprivation of liberty
Inability to give a consent
Established cognitive alteration
Contraindication to MRI (per MRI safety checklist)
Severe chronic psychiatric illness

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

The study will enroll patients with DYT-SGCE and Healthy Volunteers (HVs).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuel Roze, Md, PhD	Department of neurology, Pitié-Salpêtrière Hospital, Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brain Institute		Paris	Paris	75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29952836	Background	Roze E, Lang AE, Vidailhet M. Myoclonus-dystonia: classification, phenomenology, pathogenesis, and treatment. Curr Opin Neurol. 2018 Aug;31(4):484-490. doi: 10.1097/WCO.0000000000000577.
26783545	Background	Peall KJ, Dijk JM, Saunders-Pullman R, Dreissen YE, van Loon I, Cath D, Kurian MA, Owen MJ, Foncke EM, Morris HR, Gasser T, Bressman S, Asmus F, Tijssen MA. Psychiatric disorders, myoclonus dystonia and SGCE: an international study. Ann Clin Transl Neurol. 2015 Nov 20;3(1):4-11. doi: 10.1002/acn3.263. eCollection 2016 Jan.