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NCT07729748

Predicting Parkinson's Disease Before It Strikes: A Brain Imaging Study in At-Risk Individual

Sponsor: IRCCS San Raffaele

View on ClinicalTrials.gov

Summary

This study aims to characterize neurodegeneration progression in patients with polysomnography (PSG)-confirmed longstanding idiopathic REM sleep behavior disorder (iRBD) and to develop a prognostic model for clinical evolution and earlier identification of cases at risk of short-term conversion to clinically defined Parkinson's disease (PD). The study uses a multiparametric approach combining longitudinal clinical, neuropsychological, quantitative PSG, and multiparametric brain MRI markers (structural MRI, diffusion tensor imaging, resting-state functional MRI) to track neurodegeneration from the prodromal stage of PD and predict individual disease evolution. 50 patients with PSG-confirmed iRBD (duration since diagnosis greater than or equal to 5 years) and 50 age- and sex-matched healthy controls will be assessed at baseline and every year for 3 years at IRCCS Ospedale San Raffaele, Milan, Italy.

Official title: Tracking and Predicting Neurodegeneration Along the Parkinson's Disease Continuum Using Clinical, Cognitive and Advanced MRI Data

Key Details

Gender

All

Age Range

50 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2020-12-04

Completion Date

2027-08-01

Last Updated

2026-07-28

Healthy Volunteers

Yes

Conditions

Idiopathic REM Sleep Behavior Disorder Parkinson Disease Neurodegeneration Prodromal Parkinson Disease

Interventions

OTHER

Multiparametric clinical, neuropsychological, PSG and MRI assessment

All participants undergo multiparametric longitudinal assessments at baseline and every year for 3 years, including: clinical and neuropsychological evaluation, motor assessment using inertial sensors, quantitative polysomnography (PSG) recording, and multiparametric brain MRI on a 3.0 Tesla system (Ingenia CX Philips) including 3D T1-weighted structural MRI, diffusion tensor (DT) MRI, and resting-state fMRI. Healthy controls undergo PSG at baseline only (to exclude sleep disorders) and motor, neuropsychological and MRI assessments at baseline and every year for 3 years.

Inclusion Criteria (both patients and healthy controls): 1. Right-handed participants. 2. Monolingual native Italian speakers. 3. Age between 50 and 75 years old. 4. Normal or corrected-to-normal visual acuity. 5. Mini Mental State Examination (MMSE) score greater than 24. 6. Oral and written informed consent to study participation. Additional inclusion criteria for iRBD patients: 7. Diagnosis of iRBD based on International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria: presence of REM sleep without atonia; presence of sleep-related injurious-disruptive behaviors by history or abnormal sleep behaviors documented during PSG monitoring; absence of EEG epileptiform activity during REM sleep; presence of sleep disturbance not better explained by another sleep disorder, medical or neurologic disorder, mental disorder, medication use, or substance use disorder. 8. PSG-confirmed iRBD duration since diagnosis equal or greater than 5 years. 9. Absence of clinically defined Parkinson's disease. Exclusion Criteria for iRBD patients: 1. Secondary forms of RBD on the basis of historical data, neurologic examination, and cerebral MRI findings. 2. History of other systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan. 3. Alcohol and/or psychotropic drugs abuse. 4. Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia). Exclusion Criteria for Healthy Controls: 1. Sleep disorders on the basis of clinical evaluation. 2. History of systemic, neurologic, or psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at MRI scan. 3. Alcohol and/or psychotropic drugs abuse. 4. Contraindications to MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with the magnetic field generated by MRI, claustrophobia). 5. Hypnotic or benzodiazepine medication.

Locations (2)

San Raffaele Hospital - Sleep Disorders Center, Department of Neurology, Turro

Milan, Milano, Italy

San Raffaele Neurology Unit - Neuroimaging Research Unit