Parkinson DiseaseeyebrainparkNCT04212637
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
A study testing MRI in people with Parkinson Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2021to Jan 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Visual acuity normal or corrected to normal
- Affiliation to a social security scheme (copy of the vital card in support)
- Signed informed consent
- Medical examination according to the participation in the MRI examination
- MMSE score> 23/30
- For Parkinson patient:
Show all 9Show fewer
- Diagnosis of Parkinson's disease
- Presence of asymmetric bradykinesia and rest tremor and / or stiffness
- Hoehn \& Yahr Stadium I-II / V
Who cannot join
- Unprotected Majors unable to express their consent
- Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
- Significant hearing or motor impairment
- Past or present neuropsychiatric pathology (except benign epilepsy)
- Taking narcotics and / or drugs for neurocognitive purposes
- Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
Show all 9Show fewer
- Any other neurodegenerative pathology or treatment that may affect the oculomotor control
- For Parkinson patient:
- Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).
Trial locations and contacts
1 site in 1 country.
Louise KAUFFMANN contact
France1 site
CHU Grenoble-Alpes
Grenoble, 38043
Tiphaine Montagnon, 476766814 ext. 0033, tmontagnon@chu-grenoble.fr
Arnaud ATTYE, MD
About this study
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).
- Conditions
- Parkinson Disease
- Being tested
- MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Also called eyetracking
Examine BOLD activity in relation to eye movements measures
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | MRI exam Receives: Other: MRI |
| Parkinson patient | Experimental | MRI exam Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI images
Functional and anatomical brain volumes
Measured: 1 hour
Secondary outcomes (2)
Eye latency
latency (milliseconds) of ocular saccades
Measured: 1 hour
eye amplitude
amplitude (degree) of ocular saccades
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2019
- Study startJan 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04212637
- Sponsor's protocol ID
- 38RC18.214
- Acronym
- eyebrainpark
- Status last verified
- Nov 2020
- First submitted
- 30 Oct 2018
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
- ClinicalTrials.gov ID
- NCT04212637
- Acronym / sponsor ID
- eyebrainpark / 38RC18.214
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Laboratoire de Psychologie et NeuroCognition
- Study start
- Jan 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 27 Dec 2019 (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.
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Other: MRIMRI exam |
| Parkinson patient | Experimental | Other: MRIMRI exam |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Visual acuity normal or corrected to normal
- Affiliation to a social security scheme (copy of the vital card in support)
- Signed informed consent
- Medical examination according to the participation in the MRI examination
- MMSE score> 23/30
Key exclusion criteria (9 listed)
- Unprotected Majors unable to express their consent
- Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
- Significant hearing or motor impairment
- Past or present neuropsychiatric pathology (except benign epilepsy)
- Taking narcotics and / or drugs for neurocognitive purposes
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 |
|---|---|---|
| MRIAlso: eyetrackingExamine BOLD activity in relation to eye movements measures | Other | Healthy Volunteers, Parkinson patient |
Primary outcome
MRI images
Time frame: 1 hour
Functional and anatomical brain volumes
2 secondary outcomes
Eye latency
Time frame: 1 hour
eye amplitude
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Louise KAUFFMANN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Parkinson Disease, run by University Hospital, Grenoble 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 9 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: status not confirmed, as of the sponsor's last update on 17 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carole PEYRIN, PhD ((0)4 7682-5879 ext. 0033, carole.peyrin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI images (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2020.