EMOTION & COGNITION IN MYOCLONUS DYSTONIA (AGENT10-ECODYST)

January 3, 2023 updated by: Institut National de la Santé Et de la Recherche Médicale, France

CEREBELLAR INVOLVEMENT IN MOTOR, COGNITIVE AND EMOTIONAL PROCESSES IN MYOCLONUS DYSTONIA

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Eligibility:

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

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75013
        • Brain Institute
        • Contact:
          • Clement Tarrano, MD
        • Sub-Investigator:
          • Yulia Worbe, MD, PhD
        • Sub-Investigator:
          • Clément Tarrano, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
DYT-SGCE
Patients with myoclonus dystonia (DYT-SGCE)
Healthy volunteers
Control group

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Emmanuel Roze, Md, PhD, Department of neurology, Pitié-Salpêtrière Hospital, Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

November 1, 2026

Study Completion (Anticipated)

November 1, 2026

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Estimate)

January 4, 2023

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C22-18
  • 2022-A00786-37 (Other Identifier: ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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