Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients
PARKONTHEWAY
1 other identifier
interventional
78
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2015
CompletedFirst Submitted
Initial submission to the registry
February 11, 2019
CompletedFirst Posted
Study publicly available on registry
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedApril 10, 2024
May 1, 2020
3.8 years
February 11, 2019
April 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait profile Score (GPS) in PD and PSP patients
GPS quantifies the gait pattern deviation of the patient respect to normality range
18 months
Study Arms (3)
PD patients: Parkinson's disease group
ACTIVE COMPARATORDiagnosis 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)
PSP patients
ACTIVE COMPARATORApplication 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)
HC: healthy control group
ACTIVE COMPARATORHealthy 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)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of epileptic seizures, head injury, other neurological disorders.
- Cardiac pacemaker implantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Casa di cura San Raffaele Cassino
Cassino, Frosinone, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fabrizio Stocchi, MD, PhD
IRCCS San Raffaele Pisana
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2019
First Posted
February 15, 2019
Study Start
September 23, 2015
Primary Completion
July 25, 2019
Study Completion
July 31, 2019
Last Updated
April 10, 2024
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share