Evaluating eye movement in patients with Parkinson's disease
Video-oculography and Parkinson's Disease: A Prospective Study
This study is testing how eye movements change in people with mild to moderate Parkinson's disease over seven years to see if these changes can help track the disease and how medications affect them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Association de Recherche Bibliographique pour les Neurosciences Academic / other |
| Locations | 1 site (Monaco) |
| Trial ID | NCT04731246 on ClinicalTrials.gov |
What this trial studies
This study investigates the progression of eye movement markers in patients with mild to moderate Parkinson's disease over a seven-year period. It aims to correlate neurological and neuropsychological evaluations with eye movement assessments using video-oculography. Additionally, the study will assess the impact of antiparkinsonian medications on eye movement evolution and determine the potential of eye movement assessments as a marker for disease progression.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with idiopathic Parkinson's disease in mild to moderate stages, with some cognitive impairment allowed.
Not a fit: Patients with significant psychiatric or neurological comorbidities, or those with severe brain MRI findings, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the progression of Parkinson's disease and improve monitoring and treatment strategies for patients.
How similar studies have performed: While the use of video-oculography in Parkinson's disease is a relatively novel approach, similar studies have shown promise in understanding motor and cognitive functions.
Eligibility criteria
Show full inclusion / exclusion criteria
\*Inclusion Criteria:
1. Male or Female;
2. Clinically defined idiopathic Parkinson's Disease (PD);
3. Brain MRI performed in routine care in the 12 months preceding inclusion;
4. Cerebral DaTSCAN or cerebral PET with F-DOPA, performed as routine care before inclusion (no time limit), confirming presynaptic dopaminergic denervation;
5. Hoehn \& Yahr score: 1 to 3;
6. Normal clinical examination of oculomotricity (slight impairment of smooth pursuit accepted);
7. Neuro-cognitive disorders: absent or minor (according to DSM5);
8. Sufficient written and oral expression in French;
9. Covered by a health insurance system;
10. Written informed consent signed by the patient;
11. Presence of a caregiver.
\* Exclusion Criteria:
12. Psychiatric comorbidity (except anxiety or mild to moderate depression);
13. Neurological comorbidity, if significant;
14. Brain MRI showing:
1. significant cerebrovascular pathology (Fazekas I admitted),
2. another brain disease, including stroke.
15. Major cognitive impairment;
16. 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
17. Normal MIBG myocardial scintigraphy (if performed).
Where this trial is running
Monaco
- Centre Mémoire / Centre de Gérontologie Clinique Rainier III / Princess Grace Hospital — Monaco, Monaco (Recruiting)
Study contacts
- Principal investigator: Sandrine LOUCHART DE LA CHAPELLE, MD-PHD — Centre Mémoire, Centre de Gérontologie Clinique RAINIER III, Princess Grace Hospital, Monaco
- Study coordinator: Solange HESSE
- Email: solange.hesse@chpg.mc
- Phone: +377 99995599
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.