Actively Recruiting
Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-11-08
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying individuals with isolated Rapid Eye Movement (REM) Sleep Behavior Disorder (iRBD) to better understand how this condition progresses and to identify markers that might predict the development of Parkinson's disease, dementia with Lewy bodies, or multiple system atrophy. The study uses artificial intelligence to analyze brain imaging data and aims to develop reliable methods to forecast and categorize patients at risk of converting to these neurodegenerative diseases. Participants will undergo advanced imaging procedures, including PET/CT scans with 18-FDG, SPECT scans using 123 I-FP-CIT (DATSCAN), and MRI scans to rule out structural brain issues. These scans are performed using specialized equipment and specific timing protocols, such as imaging 30 minutes after injection for PET/CT and within 4 hours after injection for SPECT. The study is designed as an interventional trial focusing on imaging devices. Throughout the study, participants will be clinically assessed, and imaging results will be collected and analyzed to evaluate the accuracy of deep learning models in predicting disease progression over a follow-up period expected to last 48 months. The main outcome is to measure how well the AI model predicts neurodegenerative conversion in iRBD patients. Secondary outcomes include comparing predicted and actual conversion risks and evaluating the model's accuracy specifically for Parkinson's disease conversion. Participants will be monitored regularly to ensure safety and data quality during the study period.
CONDITIONS
Brief Title
Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed clinical isolated REM Sleep Behavior Disorder diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
- Written informed consent
- Age 18 years or older
You will not qualify if you...
- Known diagnosis of Parkinson's disease or other neurodegenerative disorder
- Clear signs of parkinsonism on examination
- Narcolepsy or other known causes of REM Sleep Behavior Disorder
- Moderate to severe obstructive sleep apnea
- Abnormal neurological or MRI examination
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo molecular imaging and MRI to assess brain function and exclude structural anomalies.
1 visit (in-person) including PET/CT, SPECT, and MRI scans
Duration - Up to 48 months
Participants are followed for up to 48 months to monitor neurodegenerative conversion and assess the accuracy of AI-based predictions.
Periodic visits for assessments during follow-up (visit schedule may vary)
Trial Site Locations
Total: 1 location
1
Inselspital, University Clinic for Nuclear Medicine
Bern, Switzerland, 3010
Actively Recruiting
Research Team
A
Axel Rominger, Prof. Dr. med.
F
Franziska Strunz, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here