Improve diagnostic imaging for tremor
- Trial ID
- NCT05698810
- Official Title
- Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
- Goal
- Improve diagnostic imaging for tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University Hospital, Grenoble
- Study Type
- INTERVENTIONAL
- Enrollment
- 150 participants
- Conditions
- Healthy Volunteers, Parkinson's Disease Patients, Para/Tetraplegic Patients
- Interventions
- CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability, CE marked Medical Device Magnetic Resonance Imaging (MRI) usability, CE marked Medical Device ElectroEncephaloGraphy (EEG) usability, CE marked Medical Device ElectroCardioGraphy (ECG) usability
Summary For Families
PRELUDE wants to make sure standard brain and heart exams can be done comfortably and reliably in people with Parkinson's, healthy volunteers, and people with para- or tetraplegia before larger studies. Volunteers will complete CE marked MEG, MRI, EEG and ECG sessions so the team can test usability, tolerability and data quality; MEG records tiny magnetic fields from brain activity, EEG records electrical brain waves, MRI gives detailed images of brain structure and function, and ECG tracks heart rhythm. The trial is enrolling adults 18 and older who can give informed consent and are affiliated with a social security scheme, while pregnant or breastfeeding people, those under legal protection, or otherwise excluded by the protocol are not eligible.
Locations
- Clinatec Cea/Chuga, Grenoble, France
Frequently Asked Questions
- What is this trial testing?
- This trial is studying CE marked Medical Device MagnetoEncephaloGraphy (MEG) usability. PRELUDE wants to make sure standard brain and heart exams can be done comfortably and reliably in people with Parkinson's, healthy volunteers, and people with para- or tetraplegia before larger studies. Volunteers will complete CE marked MEG, MRI, EEG and ECG sessions so the team can test usability, tolerability and data quality; MEG records tiny magnetic fields from brain activity, EEG records electrical brain waves, MRI gives detailed images of brain structure and function, and ECG tracks heart rhythm. The trial is enrolling adults 18 and older who can give informed consent and are affiliated with a social security scheme, while pregnant or breastfeeding people, those under legal protection, or otherwise excluded by the protocol are not eligible.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 10 years.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.