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Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients (PARKONTHEWAY)

Primary Purpose

Parkinson Disease (PD), Paralysis; Supranuclear

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
3D gait analysis
rsfMRI
Montreal Cognitive assesment (MoCA)
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Parkinson Disease (PD) focused on measuring 3D-gait analysis, Magnetic Resonance Imaging

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosis of idiopathic PD by United Kingdom (UK) Brain Bank criteria and PSP according to NINDS-SPSP criteria, without other significant neurological or orthopedic problems;
  • ages of 20-80;
  • able to walk 25 feet unassisted and without any assistive device

Exclusion Criteria:

  • History of epileptic seizures, head injury, other neurological disorders.
  • Cardiac pacemaker implantation

Sites / Locations

  • Casa di cura San Raffaele Cassino

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

PD patients: Parkinson's disease group

PSP patients

HC: healthy control group

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

Gait profile Score (GPS) in PD and PSP patients
GPS quantifies the gait pattern deviation of the patient respect to normality range

Secondary Outcome Measures

Full Information

First Posted
February 11, 2019
Last Updated
May 6, 2020
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT03840252
Brief Title
Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients
Acronym
PARKONTHEWAY
Official Title
Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients: a Longitudinal Prospective Study for Correlation Between Clinical Manifestations, Gait Analysis and Functional/Diffusion MRI
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 23, 2015 (Actual)
Primary Completion Date
July 25, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease (PD), Paralysis; Supranuclear
Keywords
3D-gait analysis, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PD patients: Parkinson's disease group
Arm Type
Active Comparator
Arm Description
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)
Arm Title
PSP patients
Arm Type
Active Comparator
Arm Description
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)
Arm Title
HC: healthy control group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Diagnostic Test
Intervention Name(s)
3D gait analysis
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
rsfMRI
Other Intervention Name(s)
resting state functional magnetic resonance (rsfMRI)
Intervention Description
MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).
Intervention Type
Diagnostic Test
Intervention Name(s)
Montreal Cognitive assesment (MoCA)
Intervention Description
Standard clinical questionnaire
Primary Outcome Measure Information:
Title
Gait profile Score (GPS) in PD and PSP patients
Description
GPS quantifies the gait pattern deviation of the patient respect to normality range
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis of idiopathic PD by United Kingdom (UK) Brain Bank criteria and PSP according to NINDS-SPSP criteria, without other significant neurological or orthopedic problems; ages of 20-80; able to walk 25 feet unassisted and without any assistive device Exclusion Criteria: History of epileptic seizures, head injury, other neurological disorders. Cardiac pacemaker implantation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrizio Stocchi, MD, PhD
Organizational Affiliation
IRCCS San Raffaele Pisana
Official's Role
Study Director
Facility Information:
Facility Name
Casa di cura San Raffaele Cassino
City
Cassino
State/Province
Frosinone
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients

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