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Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients

NCT03840252 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-04-10

No results posted yet for this study

Summary

This longitudinal study aims to research cognitive and gait phenotypes of Parkinson's disease and Supranuclear Palsy as well as to provide markers to track diseases progression using a multi-modality approach based on 3D-gait analysis and MR Imaging.

Specifically, this study want to identify cognitive pattern and gait-related cerebral diffusion/functional connectivity in PD and PSP patients and to verify their progression over a period of 18 months.

In summary, the current protocol proposed to investigate the following issues:

* to perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to a control group in order to categorize cognitive and gait pattern in the group of patients and verify if the gait can be useful as discriminator for diagnosis.
* to analyze whether diffusion and resting-state functional connectivity indices are correlated with clinical disease severity scores and motor scores and how they change over time (18 months later).

Conditions

  • Parkinson Disease (PD)
  • Paralysis; Supranuclear

Interventions

DIAGNOSTIC_TEST

3D gait analysis

Computed analysis of posture and gait pattern and motor performance by kinematic and kinetics parameters analysis such as the step length, gait velocity, stride time variability, 3D joint kinematics, ground reaction forces, joint kinetics

DIAGNOSTIC_TEST

rsfMRI

MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).

DIAGNOSTIC_TEST

Montreal Cognitive assesment (MoCA)

Standard clinical questionnaire

Sponsors & Collaborators

  • IRCCS San Raffaele Roma

    lead OTHER

Principal Investigators

  • Fabrizio Stocchi, MD, PhD · IRCCS San Raffaele Pisana

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-09-23
Primary Completion
2019-07-25
Completion
2019-07-31

Countries

  • Italy

Study Locations

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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 NCT03840252 on ClinicalTrials.gov