<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03840252</url>
  </required_header>
  <id_info>
    <org_study_id>RP 06/15</org_study_id>
    <nct_id>NCT03840252</nct_id>
  </id_info>
  <brief_title>Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients</brief_title>
  <acronym>PARKONTHEWAY</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This longitudinal study aims to research cognitive and gait phenotypes of Parkinson's disease&#xD;
      and Supranuclear Palsy as well as to provide markers to track diseases progression using a&#xD;
      multi-modality approach based on 3D-gait analysis and MR Imaging.&#xD;
&#xD;
      Specifically, this study want to identify cognitive pattern and gait-related cerebral&#xD;
      diffusion/functional connectivity in PD and PSP patients and to verify their progression over&#xD;
      a period of 18 months.&#xD;
&#xD;
      In summary, the current protocol proposed to investigate the following issues:&#xD;
&#xD;
        -  to perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to&#xD;
           a control group in order to categorize cognitive and gait pattern in the group of&#xD;
           patients and verify if the gait can be useful as discriminator for diagnosis.&#xD;
&#xD;
        -  to analyze whether diffusion and resting-state functional connectivity indices are&#xD;
           correlated with clinical disease severity scores and motor scores and how they change&#xD;
           over time (18 months later).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gait disorder is one of the key features of Parkinson's disease (PD), often leading to loss&#xD;
      of mobility and severe disability. Yet in the early stages of disease, examination of gait&#xD;
      may lead to inconclusive results for differential diagnosis between PD and other parkinsonism&#xD;
      because slow and small stepped walking is often unspecific and can be related to age,&#xD;
      depressive mood, or to a presence of neurodegenerative atypical parkinsonism (AP) such as&#xD;
      Progressive Supranuclear Palsy (PSP).&#xD;
&#xD;
      At the same time, emerging evidence indicates that early disturbances in cognitive processes&#xD;
      such as attention, executive function, and working memory are associated with slower gait and&#xD;
      gait instability during single and dual-task testing.&#xD;
&#xD;
      It is therefore crucial to carefully investigate the multiple cognitive domains in order to&#xD;
      identify possible mild cognitive deficits in PD and PSP patients and to correlate them with&#xD;
      gait disorders.&#xD;
&#xD;
      The use of quantitative movement analysis with 3D-gait analysis allow an objective&#xD;
      multifactorial evaluation of the functional limitation related to PD and PSP patients and can&#xD;
      be used to analyze the gait in pathologies characterized by gait impairment compared to&#xD;
      healthy control (HC).&#xD;
&#xD;
      This longitudinal clinical study aims to analyze cognitive profiles and gait pattern (with&#xD;
      3D-gait analysis) and their progression (18 months later) in a PD- and a PSP-group, respect&#xD;
      to HC group.&#xD;
&#xD;
      Moreover, with the Magnetic Resonance Imaging (MRI), the study want to research for possible&#xD;
      gait-related cerebral diffusion/functional connectivity alterations and their changes over&#xD;
      time.&#xD;
&#xD;
      The specific aims of the project are:&#xD;
&#xD;
        -  To perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to&#xD;
           a control group in order to categorize the gait in the group of patients and verify if&#xD;
           the gait can be useful as discriminator for diagnosis.&#xD;
&#xD;
        -  To detect possible cognitive deficits in Parkinson's Disease and PSP more corelated with&#xD;
           gait disturbances.&#xD;
&#xD;
        -  To analyze whether diffusion and resting-state functional connectivity indices are&#xD;
           correlated with clinical disease severity scores and motor scores and how they change&#xD;
           over time (18 months later).&#xD;
&#xD;
        -  To identify gait-related cerebral diffusion/functional connectivity in PD and PSP&#xD;
           patients and to verify their progression over a period of 18 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2015</start_date>
  <completion_date type="Actual">July 31, 2019</completion_date>
  <primary_completion_date type="Actual">July 25, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Gait profile Score (GPS) in PD and PSP patients</measure>
    <time_frame>18 months</time_frame>
    <description>GPS quantifies the gait pattern deviation of the patient respect to normality range</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Parkinson Disease (PD)</condition>
  <condition>Paralysis; Supranuclear</condition>
  <arm_group>
    <arm_group_label>PD patients: Parkinson's disease group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.&#xD;
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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PSP patients</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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 &quot;probable&quot; 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.&#xD;
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)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HC: healthy control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Healthy adults ages 21-90 without movement disorders, psychiatric disorders, or dementia.&#xD;
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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>3D gait analysis</intervention_name>
    <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</description>
    <arm_group_label>HC: healthy control group</arm_group_label>
    <arm_group_label>PD patients: Parkinson's disease group</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>rsfMRI</intervention_name>
    <description>MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).</description>
    <arm_group_label>HC: healthy control group</arm_group_label>
    <arm_group_label>PD patients: Parkinson's disease group</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
    <other_name>resting state functional magnetic resonance (rsfMRI)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Montreal Cognitive assesment (MoCA)</intervention_name>
    <description>Standard clinical questionnaire</description>
    <arm_group_label>HC: healthy control group</arm_group_label>
    <arm_group_label>PD patients: Parkinson's disease group</arm_group_label>
    <arm_group_label>PSP patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of idiopathic PD by United Kingdom (UK) Brain Bank criteria and PSP&#xD;
             according to NINDS-SPSP criteria, without other significant neurological or orthopedic&#xD;
             problems;&#xD;
&#xD;
          -  ages of 20-80;&#xD;
&#xD;
          -  able to walk 25 feet unassisted and without any assistive device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of epileptic seizures, head injury, other neurological disorders.&#xD;
&#xD;
          -  Cardiac pacemaker implantation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fabrizio Stocchi, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>IRCCS San Raffaele Pisana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Casa di cura San Raffaele Cassino</name>
      <address>
        <city>Cassino</city>
        <state>Frosinone</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS San Raffaele</investigator_affiliation>
    <investigator_full_name>Fabrizio Stocchi, MD, PhD</investigator_full_name>
    <investigator_title>Full Professor of Neurology</investigator_title>
  </responsible_party>
  <keyword>3D-gait analysis</keyword>
  <keyword>Magnetic Resonance Imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03840252
org study id: RP 06/15
nct id: NCT03840252
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Gait profile Score (GPS) in PD and PSP patients
time frame: 18 months
description: GPS quantifies the gait pattern deviation of the patient respect to normality range
arm group label: PD patients: Parkinson's disease group
arm group type: Active Comparator
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 group label: PSP patients
arm group type: Active Comparator
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 group label: HC: healthy control group
arm group type: Active Comparator
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: 3D gait analysis
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
arm group label: HC: healthy control group
arm group label: PD patients: Parkinson's disease group
arm group label: PSP patients
intervention type: Diagnostic Test
intervention name: rsfMRI
description: MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).
arm group label: HC: healthy control group
arm group label: PD patients: Parkinson's disease group
arm group label: PSP patients
other name: resting state functional magnetic resonance (rsfMRI)
intervention type: Diagnostic Test
intervention name: Montreal Cognitive assesment (MoCA)
description: Standard clinical questionnaire
arm group label: HC: healthy control group
arm group label: PD patients: Parkinson's disease group
arm group label: PSP patients
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fabrizio Stocchi, MD, PhD
role: Study Director
affiliation: IRCCS San Raffaele Pisana
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS San Raffaele
investigator full name: Fabrizio Stocchi, MD, PhD
investigator title: Full Professor of Neurology
mesh term: Parkinson Disease
mesh term: Paralysis
sharing ipd: No