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

NCT07729748 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-07-28

No results posted yet for this 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.

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.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Principal Investigators

  • Massimo Filippi · IRCCS San Raffaele

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2027-06-01
Completion
2027-08-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07729748 on ClinicalTrials.gov