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Clinical Trials in Italy / NCT07729748
Active, not recruiting Observational

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

NCT07729748 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS San Raffaele
Phase
Observational
Started
2020-12-04
Last updated
2026-07-28

Condition(s) studied

Idiopathic REM Sleep Behavior DisorderParkinson DiseaseNeurodegenerationProdromal Parkinson Disease

Investigational drug(s) / intervention(s)

Multiparametric clinical, neuropsychological, PSG and MRI assessment

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.

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
75 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease — Baseline, 12 months, 24 months, and 36 months
    A prognostic model based on longitudinal clinical markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
  • Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease — Baseline, 12 months, 24 months, and 36 months
    A prognostic model based on longitudinal neuropsychological markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).
  • Development of a prognostic model for conversion from iRBD to clinically defined Parkinson's disease — Baseline, 12 months, 24 months, and 36 months
    A prognostic model based on longitudinal PSG markers for earlier identification of iRBD cases at risk of short-term conversion to clinically defined Parkinson's disease (PD).

Trial sites (2)

FacilityCityRegionStatus
San Raffaele Hospital - Sleep Disorders Center, Department of Neurology, Turro Milan Milano
San Raffaele Neurology Unit - Neuroimaging Research Unit Milan Milano

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07729748 on ClinicalTrials.gov ↗ ← All trials in Italy