EMOTION & COGNITION in MYOCLONUS DYSTONIA (AGENT10-ECODYST)

NCT ID: NCT05671068

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-20

Study Completion Date

2026-11-20

Brief Summary

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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

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Eligibility:

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

Conditions

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Myoclonus-Dystonia DYT11

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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DYT-SGCE

Patients with myoclonus dystonia (DYT-SGCE)

No interventions assigned to this group

Healthy volunteers

Control group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emmanuel Roze, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of neurology, Pitié-Salpêtrière Hospital, Paris

Locations

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Brain Institute

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 29952836 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26783545 (View on PubMed)

Other Identifiers

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2022-A00786-37

Identifier Type: OTHER

Identifier Source: secondary_id

C22-18

Identifier Type: -

Identifier Source: org_study_id