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

NCT06629207 | Recruiting

• 1 other identifier: 2023-00816
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Dementia, Lewy Body

Keywords

Parkinson Disease; Artificial Intelligence; REM Sleep Behavior Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Comparison of the Estimated versus Observed Annual Conversion Risk of Isolated Rapid Eye Movement Behavior Disorder (iRBD) to Neurodegenerative Disorders

  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

  From enrollment to end of follow-up period, expected to be 48 months

Study Arms (1)

NUK-RB Study

EXPERIMENTAL

Device: PET/CT with 18-FDG; Device: SPECT : 123 I-FP-CIT (DATSCAN); Device: MRI

Interventions

PET/CT with 18-FDG DEVICE

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.

NUK-RB Study

SPECT : 123 I-FP-CIT (DATSCAN) DEVICE

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.

NUK-RB Study

MRI DEVICE

MRI examination to exclude structural brain anomalies.

NUK-RB Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed clinical iRBD diagnosis by movement disorder specialists according to the International Classification of Sleep Disorders
• Written informed consent

You may not qualify if:

• Known diagnosis of PD or other neurodegenerative disorder
• Unequivocal signs of parkinsonism on examination
• Narcolepsy or other known causes of RBD
• Moderate to severe obstructive sleep apnea
• Abnormal neurological or MRI examination

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital, University Clinic for Nuclear Medicine

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder; Lewy Body Disease

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders; Dementia; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Kuanggyu Shi, Prof. Dr. ing.

  University Bern, Inselspital, Center for Artificial Intelligence in Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Rominger, Prof. Dr. med.

CONTACT

+41 316322610; axel.rominger@insel.ch

Franziska Strunz, PhD

CONTACT

+41 316643022; studies.nuk@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 8, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)