Myoclonus-DystoniaNCT05671068
EMOTION & COGNITION IN MYOCLONUS DYSTONIA (AGENT10-ECODYST)
An observational study of Myoclonus-Dystonia and DYT11, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Myoclonus-Dystonia, DYT11
- How many people
- 47 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2023to 19 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study will enroll patients with DYT-SGCE and Healthy Volunteers (HVs).
Who may be able to join
- 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
Show all 9Show fewer
- For controls:
- No neurological symptoms
- No medication except oral contraception
Who cannot join
- No deprivation of liberty
- Inability to give a consent
- Established cognitive alteration
- Contraindication to MRI (per MRI safety checklist)
- Severe chronic psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
Eligibility:
DYT-SGCE patients and healthy volunteers (HV) between 15 and 60 years old.
- Conditions
- Myoclonus-Dystonia, DYT11
- Medical subject headings
- Myoclonic dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| DYT-SGCE | Patients with myoclonus dystonia (DYT-SGCE) | |
| Healthy volunteers | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal derived from the functional magnetic resonance imaging
Explore the differences in DYT-SGCE compared to HV
Measured: 46 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start20 Jan 2023
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myoclonus-DystoniaStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor
- Investigators
- Emmanuel Roze, Md, PhD, Principal investigator, Department of neurology, Pitié-Salpêtrière Hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671068
- Sponsor's protocol ID
- C22-18
- Other IDs
- 2022-A00786-37
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2022
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29952836Peall 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.
PubMed 26783545
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CEREBELLAR INVOLVEMENT IN MOTOR, COGNITIVE AND EMOTIONAL PROCESSES IN MYOCLONUS DYSTONIA
- ClinicalTrials.gov ID
- NCT05671068
- Acronym / sponsor ID
- C22-18
- Conditions
- Myoclonus-Dystonia, DYT11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- Assistance Publique - Hôpitaux de Paris
- Study start
- 20 Jan 2023 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DYT-SGCE | – | –Patients with myoclonus dystonia (DYT-SGCE) |
| Healthy volunteers | – | –Control group |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will enroll patients with DYT-SGCE and Healthy Volunteers (HVs).
Key inclusion criteria (9 listed)
- Age between 15-60 years
- Able to give informed consent.
- An established diagnostic of DYT-SGCE
- No change in medication (related to DYT-SGCE) for a month
- No neurological symptoms
Key exclusion criteria (5 listed)
- No deprivation of liberty
- Inability to give a consent
- Established cognitive alteration
- Contraindication to MRI (per MRI safety checklist)
- Severe chronic psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BOLD signal derived from the functional magnetic resonance imaging
Time frame: 46 month
Explore the differences in DYT-SGCE compared to HV
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Background: PubMed 29952836Roze 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.
- Background: PubMed 26783545Peall 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Roze, Md, PhD principal investigator
Department of neurology, Pitié-Salpêtrière Hospital, Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myoclonus-Dystonia and DYT11, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal derived from the functional magnetic resonance imaging (time frame: 46 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671068, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.