Artificial Intelligence in Molecular Imaging: Predicting Parkinson's Risk in REM Sleep Behavior Disorder (NUK-RBD)

Artificial Intelligence on Molecular Imaging to Predict the Risks of Parkinson's Disease for Patients With Rapid Eye Movement Sleep Behavior Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; REM Sleep Behavior Disorder; Dementia, Lewy Body
• Intervention / Treatment: Device: PET/CT with 18-FDG; Device: SPECT : 123 I-FP-CIT (DATSCAN); Device: MRI

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Axel Rominger, Prof. Dr. med.; Phone Number: +41 316322610; Email: axel.rominger@insel.ch
• Study Contact Backup: Name: Franziska Strunz, PhD; Phone Number: +41 316643022; Email: studies.nuk@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Inselspital, University Clinic for Nuclear Medicine
    • Contact: Axel Rominger, Prof. Dr. med.; Phone Number: +41 31 632 26 10; Email: axel.rominger@insel.ch
    • Contact: Franziska Strunz, PhD; Phone Number: +41 31 66 4 30 22; Email: studies.nuk@insel.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: NUK-RB Study

Device: PET/CT with 18-FDG; FDG-PET scans will be acquired in a Siemens Biograph Vision Quadra PET/CT (Siemens, Germany) at 30-minute post-injection of approximately 80 MBq 18F-FDG. The duration of the acquisition is 20 minutes. The PET images will be reconstructed with the vendor's time of flight (TOF) point-spread-function (PSF) algorithm, following corrections for randoms, scatter, and decay. Attenuation correction will be performed first using low-dose CT.; Device: SPECT : 123 I-FP-CIT (DATSCAN); DaT-Scans will be acquired in a GE Discovery NM/CT 670 Pro™. After injection of approximately 110 MBq 123I-FP-CIT, images will be acquired within 4 h post-injection. The duration of the acquisition is 35 minutes.; Device: MRI; MRI examination to exclude structural brain anomalies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Deep Learning Model Accuracy in Predicting Neurodegenerative Conversion in isolated REM sleep behavior disorder (iRBD) through Early Biomarker Detection	The investigators aim to evaluate the predictive accuracy of a deep learning model in identifying patients with iRBD who will progress to a neurodegenerative disorder. The primary outcome will assess the model's sensitivity in detecting early imaging biomarkers linked to disease progression, with the goal of enabling earlier intervention and improving long-term outcomes.	From enrollment to end of follow-up period, expected to be 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders	The investigators aim to compare the estimated annual conversion risk of 6.3% in patients with iRBD to Parkinson's disease or another overt alpha-synucleinopathy with the conversion rates observed in the study.	From enrollment to end of follow-up period, expected to be 48 months
Evaluation of Deep Learning Model Accuracy in Predicting Conversion of Isolated REM Sleep Behavior Disorder (iRBD) to Parkinson's Disease	The investigators aim to evaluate the accuracy, receiver operating characteristic curves and area under the curve, specificity, and positive and negative predictive values of the applied deep learning method, predicting the conversion risk from iRBD to Parkinson's disease or another overt alpha-synucleinopathy.	From enrollment to end of follow-up period, expected to be 48 months

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Kuanggyu Shi, Prof. Dr. ing., University Bern, Inselspital, Center for Artificial Intelligence in Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 4, 2024
• First Posted (Actual): October 8, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Parkinson Disease; Artificial Intelligence; REM Sleep Behavior Disorder
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parasomnias; REM Sleep Parasomnias; Mental Disorders; Parkinson Disease; Lewy Body Disease; REM Sleep Behavior Disorder; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2023-00816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No