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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD patients: Parkinson's disease group | Active Comparator | Diagnosis of idiopathic PD by United Kingdom Brain Bank criteria, exclusion of other significant neurological or orthopedic problems; ages of 21-90; able to walk 25 feet unassisted and without any assistive device. Imaging: rsfMRI, diffusion tensor imaging; Motor evaluation: 3D gait analysis; Movement Disorder Society (MDS)-UPDRS Behavioral: PD-MCI-specific Level II battery (Mov Dis. 2015 Mar; 30(3): 402-406) |
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| PSP patients | Active Comparator | Application of the National Institute of Neurological Disorders and Stroke and Society for Progressive Supranuclear Palsy (NINDS-SPSP) criteria for the clinical diagnosis of "probable" PSP, evaluation of PSP rating scale, exclusion of other significant neurological or orthopedic problems; ages of 21-90; able to walk 25 feet unassisted and without any assistive device. Imaging: rsfMRI, diffusion tensor imaging; Motor evaluation: 3D gait analysis;MDS-UPDRS Behavioral: PD-MCI-specific Level II battery (Mov Dis. 2015 Mar; 30(3): 402-406) |
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| HC: healthy control group | Active Comparator | Healthy adults ages 21-90 without movement disorders, psychiatric disorders, or dementia. Imaging: rsfMRI, diffusion tensor imaging; Motor evaluation: 3D gait analysis; Behavioral: PD-Mild Cognitive Impairment (MCI)-specific Level II battery (Mov Dis. 2015 Mar; 30(3): 402-406) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D gait analysis | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gait profile Score (GPS) in PD and PSP patients | GPS quantifies the gait pattern deviation of the patient respect to normality range | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Stocchi, MD, PhD | IRCCS San Raffaele Pisana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa di cura San Raffaele Cassino | Cassino | Frosinone | Italy |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| rsfMRI | Diagnostic Test | MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany). |
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| Montreal Cognitive assesment (MoCA) | Diagnostic Test | Standard clinical questionnaire |
|
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |