HealthyMOUVADOCNCT01495897
Abnormal Movements, Cerebellum and Sensorimotor : Oculomotor Study
A study testing Tracking eye movement and Tracking eye movement under deep brain stimulation in people with Healthy and Dystonia, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Dystonia, Parkinson Disease
- What is being tested?
- Tracking eye movement and Tracking eye movement under deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2011to Mar 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- -normal cognitive functions (>24y)
- Normal clinical examination of ocular mobility, visualization of the target
- No drug potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug, antiepileptic.
- Dystonia or essential tremor or Parkinson: diagnostic made by a neurologist
- For DYT11: mutation in SGCE gene.
Show all 14Show fewer
- For dystonia: No secondary dystonia
- For Parkinson : UPDRS<28
- No other neurological disorder
- For the patient having deep brain stimulation:
- Duration of stimulation> 6 months
- Cerebral imagery post operation made
- Stimulation parameter stable since 3 months at least.
- Usual stop of the stimulation during the night
Who cannot join
- Uncontrollable medical problems not related to M-D
- Current active psychiatric disorder
- Intake during the last 3 days of drugs potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug
- Subjects legally protected.
- Subjects who are not enrolled at social security.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation Sensorimotrice, Cervelet et Mouvements Anormaux: Projet d'étude Oculomotrice
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested.
The investigators propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.
Read more
Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between pre-test and post-test.
Expected results:
- no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
- abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.
Read the detailed description
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. High frequency stimulation of the ventral intermedius nucleus (Vim) of the thalamus, relay for the cerebellar output, is successfully used for the treatment of severe essential tremor. It occasionally induces adverse event such as balance disorders or cerebellar symptoms. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested. It seems that dystonia and essential tremor could be the result of basal ganglia or cerebellar dysfunction, or from dysfunction of structures controlled at the same time by the cerebellum and the basal ganglia.
methodology: We propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.
A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.
The subjects will be seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location. This avoided any post-saccadic visual feedback that would counteract the adaptive mechanism. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between the pre-test and post-test.
Expected results:
- no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
- abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.
- Conditions
- Healthy, Dystonia, Parkinson Disease
- Being tested
- Tracking eye movement, Tracking eye movement under deep brain stimulation
- Keywords
- Dystonia, Cerebellar, ocular movements, DYT 11, sensorimotor integration
- Medical subject headings
- Dystonia, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking eye movementDevice
Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
Tracking eye movement under deep brain stimulationDevice
Device: studying Saccadic eye movements with a video eye tracker. If the patient has deep brain stimulation, recording will be made in the morning, before the usual morning start of the deep brain stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Other | Healthy volunteers Receives: Device: Tracking eye movement |
| Dystonia | Experimental | patients with Primary Dystonia Receives: Device: Tracking eye movement |
| Parkinson | Experimental | patients with Parkinson's disease Receives: Device: Tracking eye movement |
| Essential tremor | Experimental | patients with essential tremor with or without deep brain stimulation Receives: Device: Tracking eye movement; Device: Tracking eye movement under deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saccadic adaptation
Saccadic adaptation, evaluated as the percentage of changes in the mean saccade amplitude between the pre-test and post-test.
Measured: between the pre-test and post-test, maximum 4 hours
Characteristics of the saccade
latency, velocity, duration of the saccade
Measured: measured during the analysis of the recorded session, maximum 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emmanuel Flamand-Roze, MD, PhD, Study director, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01495897
- Sponsor's protocol ID
- C10-18
- Other IDs
- 2010-A00740-39
- Acronym
- MOUVADOC
- Status last verified
- Feb 2016
- First submitted
- 18 May 2011
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubsch C, Vidailhet M, Rivaud-Pechoux S, Pouget P, Brochard V, Degos B, Pelisson D, Golmard JL, Gaymard B, Roze E. Impaired saccadic adaptation in DYT11 dystonia. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1103-6. doi: 10.1136/jnnp.2010.232793. Epub 2011 Mar 8.
PubMed 21386109
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation Sensorimotrice, Cervelet et Mouvements Anormaux: Projet d'étude Oculomotrice
- ClinicalTrials.gov ID
- NCT01495897
- Acronym / sponsor ID
- MOUVADOC / C10-18
- Conditions
- Healthy, Dystonia, Parkinson Disease
- Keywords
- Dystonia, Cerebellar, ocular movements, DYT 11, sensorimotor integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 20 Dec 2011 (estimated)
- 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.
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested.
The investigators propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.
Eye position will be sampled with a video-based monocular eye tracker (SMI, Germany) before and immediately after an adaptation task. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between pre-test and post-test.
Expected results:
- no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
- abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.
Detailed description
Dystonia is a movement disorder characterized by involuntary, sustained, often repetitive muscle contractions of opposite muscles that lead to abnormal twisting movements or odd postures. Essential tremor is a slowly progressive neurologic disorder characterized by the appearance of a tremor during the voluntary movement. High frequency stimulation of the ventral intermedius nucleus (Vim) of the thalamus, relay for the cerebellar output, is successfully used for the treatment of severe essential tremor. It occasionally induces adverse event such as balance disorders or cerebellar symptoms. The pathophysiology of dystonia or essential tremor is not fully elucidated. Dystonia and essential tremor are associated with dysfunction of the sensorimotor basal ganglia-cortical network and involvement of the cerebellum and cerebellar pathways has also been recently suggested. It seems that dystonia and essential tremor could be the result of basal ganglia or cerebellar dysfunction, or from dysfunction of structures controlled at the same time by the cerebellum and the basal ganglia.
methodology: We propose to study 30 patients having a primary dystonia (15 DYT11 genetically documented), 15 patients having an essential tremor without deep brain stimulation and 15 patients having an essential tremor with deep brain stimulation.
A group of 30 healthy volunteers will be recruited and tested according to the same modalities. They will be paired in sex and age. 30 patients having a Parkinson disease will be also tested.
The subjects will be seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location. This avoided any post-saccadic visual feedback that would counteract the adaptive mechanism. Saccade adaptation is evaluated as the percentage change in the mean saccade amplitude between the pre-test and post-test.
Expected results:
- no or fewer alteration of the performance to the adaptation task in the Parkinson group than in the Essential Tremor group/ dystonia group.
- abnormal reactive saccade backward adaptation in the Dystonia group and Essential Tremor group, providing further neurophysiological evidence of cerebellar dysfunction.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy | Other | Device: Tracking eye movementHealthy volunteers |
| Dystonia | Experimental | Device: Tracking eye movementpatients with Primary Dystonia |
| Parkinson | Experimental | Device: Tracking eye movementpatients with Parkinson's disease |
| Essential tremor | Experimental | Device: Tracking eye movement, Device: Tracking eye movement under deep brain stimulationpatients with essential tremor with or without deep brain stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age ≥18 years
- -normal cognitive functions (>24y)
- Normal clinical examination of ocular mobility, visualization of the target
- No drug potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug, antiepileptic.
- Dystonia or essential tremor or Parkinson: diagnostic made by a neurologist
Key exclusion criteria (5 listed)
- Uncontrollable medical problems not related to M-D
- Current active psychiatric disorder
- Intake during the last 3 days of drugs potentially able to modify and to influence the data: anti-depressants, neuroleptics, anti-emetics, amphetamines, anti myoclonic/dystonic drugs, alcohol, dopaminergic drug
- Subjects legally protected.
- Subjects who are not enrolled at social security.
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 |
|---|---|---|
| Tracking eye movementDevice: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location. | Device | Dystonia, Essential tremor, Healthy, Parkinson |
| Tracking eye movement under deep brain stimulationDevice: studying Saccadic eye movements with a video eye tracker. If the patient has deep brain stimulation, recording will be made in the morning, before the usual morning start of the deep brain stimulation. | Device | Essential tremor |
Primary outcome
Saccadic adaptation
Time frame: between the pre-test and post-test, maximum 4 hours
Saccadic adaptation, evaluated as the percentage of changes in the mean saccade amplitude between the pre-test and post-test.
Characteristics of the saccade
Time frame: measured during the analysis of the recorded session, maximum 4 hours
latency, velocity, duration of the saccade
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 Sep 2025.
- Results publication: PubMed 21386109Hubsch C, Vidailhet M, Rivaud-Pechoux S, Pouget P, Brochard V, Degos B, Pelisson D, Golmard JL, Gaymard B, Roze E. Impaired saccadic adaptation in DYT11 dystonia. J Neurol Neurosurg Psychiatry. 2011 Oct;82(10):1103-6. doi: 10.1136/jnnp.2010.232793. Epub 2011 Mar 8.
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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 Flamand-Roze, MD, PhD study director
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking eye movement and Tracking eye movement under deep brain stimulation in people with Healthy and Dystonia, 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 14 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 Sep 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?
Saccadic adaptation (time frame: between the pre-test and post-test, maximum 4 hours). 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 NCT01495897, which also lists 1 linked publication.
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 Sep 2025.