TrialPath
← Back to searchRecruiting

Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder

NCT06629207 · Insel Gruppe AG, University Hospital Bern
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder
About this study
The study aims to systematically document the course of REM sleep behavior disorder (RBD) and investigate possible clinical and imaging biomarkers for disease progression and conversion risk to Parkinson's disease (PD), dementia with Lewy bodies (DLB), and multiple system atrophy (MSA). The study will use artificial intelligence to analyze imaging and develop a reliable method to predict and stratify patients approaching conversion to overt a-synucleinopathy. Participants will be clinically evaluated and 2 imaging procedures will be done.
Eligibility criteria
Inclusion Criteria: 1. Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders 2. Written informed consent Exclusion Criteria: 1. Known diagnosis of PD or other neurodegenerative disorder 2. Unequivocal signs of parkinsonism on examination 3. Narcolepsy or other known causes of RBD 4. Moderate to severe obstructive sleep apnea 5. Abnormal neurological or MRI examination
Study design
Enrollment target: 20 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-10-07
Estimated completion: 2026-08-01
Last updated: 2024-11-08
Interventions
Device: PET/CT with 18-FDGDevice: SPECT : 123 I-FP-CIT (DATSCAN)Device: MRI
Primary outcomes
  • Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection (From enrollment to end of follow-up period, expected to be 48 months)
Sponsor
Insel Gruppe AG, University Hospital Bern · other
Contacts & investigators
ContactAxel Rominger, Prof. Dr. med. · contact · axel.rominger@insel.ch · +41 316322610
ContactFranziska Strunz, PhD · contact · studies.nuk@insel.ch · +41 316643022
InvestigatorKuanggyu Shi, Prof. Dr. ing. · principal_investigator, University Bern, Inselspital, Center for Artificial Intelligence in Medicine
All locations (1)
Inselspital, University Clinic for Nuclear MedicineRecruiting
Bern, Switzerland
Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder · TrialPath