Dystonia, PrimaryAGENT10NCT03351218
Agency in Dystonia
A study testing Behavioral testing - computerized tasks in people with Dystonia, Primary, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dystonia, Primary
- What is being tested?
- Behavioral testing - computerized tasks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2017to 20 Dec 2022
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- any neurological history except for dystonia,
- history of dopamine antagonist treatment,
- secondary dystonia,
- dystonia in the upper limbs,
- inability to maintain gaze straight.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'investigation Clinique
Paris, Île-de-France Region, 75013
About this study
Official title: Neuronal Correlates of Agency in Dystonia
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.
Read the detailed 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)
- Conditions
- Dystonia, Primary
- Being tested
- Behavioral testing - computerized tasks
- Medical subject headings
- Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral testing - computerized tasksBehavioural
Cognitive behavioral testing and cerebral MRI
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | 25 patients with cervical and 25 patients with myoclonus dystonia Receives: Behavioral: Behavioral testing - computerized tasks |
| Controls | Other | 50 healthy volunteers matched to patents ( age, sex) Receives: Behavioral: Behavioral testing - computerized tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
agency tasks behavioral outcome measures
response time
Measured: throughout study completion, an average 2 years
agency tasks behavioral outcome measures
response accuracy in tasks trials
Measured: throughout study completion, an average 2 years
Secondary outcomes (2)
MRI measures
cortical thickness
Measured: throughout study completion, an average 2 years
MRI measures
basal ganglia volume
Measured: throughout study completion, an average 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start23 Oct 2017
- Primary completion15 Oct 2020
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dystonia, PrimaryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups study : patients versus healthy controls
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351218
- Sponsor's protocol ID
- C17-04
- Other IDs
- 2017-A01231-52
- Acronym
- AGENT10
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tarrano C, Lamy JC, Delorme C, McGovern EM, Atkinson-Clement C, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Apartis E, Vidailhet M, Roze E, Worbe Y. Tactile Temporal Discrimination Is Impaired in Myoclonus-Dystonia. Mov Disord. 2020 Dec;35(12):2356-2357. doi: 10.1002/mds.28253. Epub 2020 Sep 22. No abstract available.
PubMed 32960985Tarrano C, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Vidailhet M, Pouget P, Roze E, Worbe Y. Visual sensory processing is altered in myoclonus dystonia. Mov Disord. 2020 Jan;35(1):151-160. doi: 10.1002/mds.27857. Epub 2019 Sep 30.
PubMed 31571302Zito GA, Tarrano C, Jegatheesan P, Ekmen A, Beranger B, Rebsamen M, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Brissard MA, Vidailhet M, Gallea C, Roze E, Worbe Y. Somatotopy of cervical dystonia in motor-cerebellar networks: Evidence from resting state fMRI. Parkinsonism Relat Disord. 2022 Jan;94:30-36. doi: 10.1016/j.parkreldis.2021.11.034. Epub 2021 Nov 30.
PubMed 34875561Zito GA, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Worbe Y, Roze E, Gallea C. Fixel-Based Analysis Reveals Whole-Brain White Matter Abnormalities in Cervical Dystonia. Mov Disord. 2023 Jul;38(7):1187-1196. doi: 10.1002/mds.29425. Epub 2023 May 6.
PubMed 37148555Zito GA, Roze E, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Pouget P, Worbe Y, Gallea C. Abnormal Connectivity of the Head Neural Integrator in Cervical Dystonia. Mov Disord. 2025 Nov;40(11):2321-2330. doi: 10.1002/mds.70014. Epub 2025 Sep 5.
PubMed 40910449Atkinson-Clement C, Tarrano C, Porte CA, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Rosso C, Apartis E, Vidailhet M, Pouget P, Roze E, Worbe Y. Dissociation in reactive and proactive inhibitory control in Myoclonus dystonia. Sci Rep. 2020 Aug 18;10(1):13933. doi: 10.1038/s41598-020-70926-x.
PubMed 32811896
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronal Correlates of Agency in Dystonia
- ClinicalTrials.gov ID
- NCT03351218
- Acronym / sponsor ID
- AGENT10 / C17-04
- Conditions
- Dystonia, Primary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 22 Nov 2017 (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.
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.
Detailed 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)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups study : patients versus healthy controls
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Behavioral: Behavioral testing - computerized tasks25 patients with cervical and 25 patients with myoclonus dystonia |
| Controls | Other | Behavioral: Behavioral testing - computerized tasks50 healthy volunteers matched to patents ( age, sex) |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- any neurological history except for dystonia,
- history of dopamine antagonist treatment,
- secondary dystonia,
- dystonia in the upper limbs,
- inability to maintain gaze straight.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral testing - computerized tasksCognitive behavioral testing and cerebral MRI | Behavioural | Controls, Patients |
Primary outcome
agency tasks behavioral outcome measures
Time frame: throughout study completion, an average 2 years
response time
agency tasks behavioral outcome measures
Time frame: throughout study completion, an average 2 years
response accuracy in tasks trials
2 secondary outcomes
MRI measures
Time frame: throughout study completion, an average 2 years
MRI measures
Time frame: throughout study completion, an average 2 years
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 4 Dec 2025.
- Results publication: PubMed 32960985Tarrano C, Lamy JC, Delorme C, McGovern EM, Atkinson-Clement C, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Apartis E, Vidailhet M, Roze E, Worbe Y. Tactile Temporal Discrimination Is Impaired in Myoclonus-Dystonia. Mov Disord. 2020 Dec;35(12):2356-2357. doi: 10.1002/mds.28253. Epub 2020 Sep 22. No abstract available.
- Results publication: PubMed 31571302Tarrano C, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Vidailhet M, Pouget P, Roze E, Worbe Y. Visual sensory processing is altered in myoclonus dystonia. Mov Disord. 2020 Jan;35(1):151-160. doi: 10.1002/mds.27857. Epub 2019 Sep 30.
- Results publication: PubMed 34875561Zito GA, Tarrano C, Jegatheesan P, Ekmen A, Beranger B, Rebsamen M, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Brissard MA, Vidailhet M, Gallea C, Roze E, Worbe Y. Somatotopy of cervical dystonia in motor-cerebellar networks: Evidence from resting state fMRI. Parkinsonism Relat Disord. 2022 Jan;94:30-36. doi: 10.1016/j.parkreldis.2021.11.034. Epub 2021 Nov 30.
- Results publication: PubMed 37148555Zito GA, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Worbe Y, Roze E, Gallea C. Fixel-Based Analysis Reveals Whole-Brain White Matter Abnormalities in Cervical Dystonia. Mov Disord. 2023 Jul;38(7):1187-1196. doi: 10.1002/mds.29425. Epub 2023 May 6.
- Results publication: PubMed 40910449Zito GA, Roze E, Tarrano C, Ouarab S, Jegatheesan P, Ekmen A, Beranger B, Valabregue R, Hubsch C, Sangla S, Bonnet C, Delorme C, Meneret A, Degos B, Bouquet F, Apoil Brissard M, Vidailhet M, Hasboun D, Pouget P, Worbe Y, Gallea C. Abnormal Connectivity of the Head Neural Integrator in Cervical Dystonia. Mov Disord. 2025 Nov;40(11):2321-2330. doi: 10.1002/mds.70014. Epub 2025 Sep 5.
- Results publication: PubMed 32811896Atkinson-Clement C, Tarrano C, Porte CA, Wattiez N, Delorme C, McGovern EM, Brochard V, Thobois S, Tranchant C, Grabli D, Degos B, Corvol JC, Pedespan JM, Krystkoviak P, Houeto JL, Degardin A, Defebvre L, Valabregue R, Rosso C, Apartis E, Vidailhet M, Pouget P, Roze E, Worbe Y. Dissociation in reactive and proactive inhibitory control in Myoclonus dystonia. Sci Rep. 2020 Aug 18;10(1):13933. doi: 10.1038/s41598-020-70926-x.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral testing - computerized tasks in people with Dystonia, Primary, 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 4 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 4 Dec 2025. 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?
agency tasks behavioral outcome measures (time frame: throughout study completion, an average 2 years). The study lists 2 primary outcomes in all. 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 NCT03351218, which also lists 6 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 4 Dec 2025.