Feasibility testing for future clinical research protocols
Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
This study is testing different medical exams to see how well they work for future research involving healthy volunteers and patients with Parkinson's disease or paralysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05698810 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility of various examinations necessary for the development of future clinical research protocols at Clinatec. It involves testing parameters and sequences of examination times for participants, including healthy volunteers and patients with Parkinson's disease or paralysis. The study will utilize CE marked medical devices such as MagnetoEncephaloGraphy (MEG), Magnetic Resonance Imaging (MRI), ElectroEncephaloGraphy (EEG), and ElectroCardioGraphy (ECG) to gather data. The expected outcomes include optimizing clinical management and defining experimental paradigms for subsequent studies.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers and patients aged 18 and older with Parkinson's disease or para/tetraplegia.
Not a fit: Patients who are pregnant, nursing, or under legal protection measures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the design and execution of future clinical trials, leading to better patient outcomes.
How similar studies have performed: While this study focuses on feasibility, similar studies have shown success in optimizing clinical trial protocols, suggesting a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ⩾ 18 years * Affiliated to a social security scheme * Free and informed consent signed Exclusion Criteria: * Subject in a period of exclusion from another study. * Subject deprived of liberty by a judicial or administrative decision, or major subject subject to a legal protection measure (guardianship, curatorship and safeguarding of justice) referred to in Articles 1121-6 to 1121-8 of the Public Health Code. * Subject who would receive more than 4500 euros in compensation because of his participation in other research involving the human person in the 12 months preceding this study. * Pregnant woman, parturient, nursing mother (Article 1121-5 of the Public Health Code) * Subject not reachable urgently.
Where this trial is running
Grenoble
- Clinatec Cea/Chuga — Grenoble, France (Recruiting)
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.