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New treatment option for Parkinson Disease, Idiopathic
Official title Video-oculography and Parkinson's Disease
ClinicalTrials.gov ID: NCT04731246
What this study is testing
- What it's testing
- This study aims to study, in patient with Parkinson's disease, mild to moderate stage (according to Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease, Postuma et al., 2015): the evolution of oculomotricity markers over time. the correlation between neurological evaluations (motor and non-motor scores), neuropsychological evaluations (cognitive disorders) and oculomotricity evaluation, over a follow-up period of 7 years.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or Female;
- Clinically defined idiopathic Parkinson's Disease (PD);
- Brain MRI performed in routine care in the 12 months preceding inclusion;
- Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic...
- Hoehn \& Yahr score: 1 to 3;
You likely can't join if
- Psychiatric comorbidity (except anxiety or mild to moderate depression);
- Neurological comorbidity, if significant;
- Brain MRI showing:
- significant cerebrovascular pathology (Fazekas I admitted),
- another brain disease, including stroke.
- Major cognitive impairment;
See the full eligibility criteria
- Male or Female;
- Clinically defined idiopathic Parkinson's Disease (PD);
- Brain MRI performed in routine care in the 12 months preceding inclusion;
- Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
- Hoehn \& Yahr score: 1 to 3;
- Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
- Neuro-cognitive disorders: absent or minor (according to DSM5);
- Sufficient written and oral expression in French;
- Covered by a health insurance system;
- Written informed consent signed by the patient;
- Presence of a caregiver. \
- Psychiatric comorbidity (except anxiety or mild to moderate depression);
- Neurological comorbidity, if significant;
- Brain MRI showing:
- significant cerebrovascular pathology (Fazekas I admitted),
- another brain disease, including stroke.
- Major cognitive impairment;
- Absolute exclusion criteria and "Red flags" of the 2015 criteria orienting towards another degenerative pathology of the extrapyramidal system:
- Cerebellar syndrome
- Vertical oculomotricity disorders on clinical examination
- Motor symptoms restricted to the lower limbs
- Bilateral and perfectly symmetrical parkinsonism
- Early dystonia
- Clinical profile suggestive of behavioral variant frontotemporal dementia (bvFTD)
- Progressive aphasia or apraxia
- Moderate or severe postural instability and / or early falls
- Early bulbar dysfunction (dysarthria, swallowing disorders)
- Ventilatory dysfunction (inspiration)
- Severe dysautonomia
- DOPA-resistance
- Neuroleptic treatment or related
- Normal MIBG myocardial scintigraphy (if performed).
The study team makes the final eligibility decision.
Where it's taking place
- Monaco, Monaco
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Monaco, Monaco. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.