Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03840252 |
| Other study ID # |
RP 06/15 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 23, 2015 |
| Est. completion date |
July 31, 2019 |
Study information
| Verified date |
May 2020 |
| Source |
IRCCS San Raffaele Roma |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
