Clinical trial NCT03840252: Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients
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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease (PD)
Paralysis; Supranuclear
Keywords: 3D-gait analysis
Magnetic Resonance Imaging
Lead sponsor: IRCCS San Raffaele Roma
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 78
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Gait profile Score (GPS) in PD and PSP patients
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cassino
country: Italy
facility: Casa di cura San Raffaele Cassino
state: Frosinone
Study officials:
affiliation: IRCCS San Raffaele Pisana
name: Fabrizio Stocchi, MD, PhD
role: STUDY_DIRECTOR
References: