Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients
Condition: Parkinson Disease (PD); Paralysis; Supranuclear
MeSH terms: Parkinson Disease; Paralysis
Study type: Interventional

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).
    

Detailed description: 
      Gait disorder is one of the key features of Parkinson's disease (PD), often leading to loss
      of mobility and severe disability. Yet in the early stages of disease, examination of gait
      may lead to inconclusive results for differential diagnosis between PD and other parkinsonism
      because slow and small stepped walking is often unspecific and can be related to age,
      depressive mood, or to a presence of neurodegenerative atypical parkinsonism (AP) such as
      Progressive Supranuclear Palsy (PSP).

      At the same time, emerging evidence indicates that early disturbances in cognitive processes
      such as attention, executive function, and working memory are associated with slower gait and
      gait instability during single and dual-task testing.

      It is therefore crucial to carefully investigate the multiple cognitive domains in order to
      identify possible mild cognitive deficits in PD and PSP patients and to correlate them with
      gait disorders.

      The use of quantitative movement analysis with 3D-gait analysis allow an objective
      multifactorial evaluation of the functional limitation related to PD and PSP patients and can
      be used to analyze the gait in pathologies characterized by gait impairment compared to
      healthy control (HC).

      This longitudinal clinical study aims to analyze cognitive profiles and gait pattern (with
      3D-gait analysis) and their progression (18 months later) in a PD- and a PSP-group, respect
      to HC group.

      Moreover, with the Magnetic Resonance Imaging (MRI), the study want to research for possible
      gait-related cerebral diffusion/functional connectivity alterations and their changes over
      time.

      The specific aims of the project are:

        -  To perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to
           a control group in order to categorize the gait in the group of patients and verify if
           the gait can be useful as discriminator for diagnosis.

        -  To detect possible cognitive deficits in Parkinson's Disease and PSP more corelated with
           gait disturbances.

        -  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).

        -  To identify gait-related cerebral diffusion/functional connectivity in PD and PSP
           patients and to verify their progression over a period of 18 months.
    

Intervention name(s): 3D gait analysis; rsfMRI; Montreal Cognitive assesment (MoCA)
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 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; MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).; Standard clinical questionnaire
Other intervention name(s): resting state functional magnetic resonance (rsfMRI)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 3D-gait analysis; Magnetic Resonance Imaging