CE marked Medical Device MagnetoEn… for Parkinson's (PRELUDE, NCT05698810)
Improve diagnostic imaging for tremor
- Trial ID
- NCT05698810
- Official Title
- Preparation and Feasibility of Exams for Expected Studies (PRELUDE)
- Study Acronym
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 10 years.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: MRI scan (non-invasive); Brain wave recording (EEG) (non-invasive); Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.