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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Written informed consent

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

  • 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.

  • MRI

    Device

    MRI examination to exclude structural brain anomalies.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: NUK-RB StudyExperimental treatment 3 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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.

Time frame
From enrollment to end of follow-up period, expected to be 48 months
2

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.

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

Other outcomes

Sponsors and contacts

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