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The Natural History of Parkinson's Disease-associated Spinal Disorders

Sponsor
Ohio State University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04101513
Collaborator
(none)
100
Enrollment
1
Location
96
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective single-institution longitudinal study to access quality of life and serial imaging and biodynamic testing to assess spinal disorders associated with Parkinson's disease patients.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a prospective single-institution longitudinal study to access quality of life with PROMIS testing, ODI, NDI, VAS and short form 36 health physical component score. The study will also include serial radiographic assessments and biodynamic force plate and hand dynamometer testing. This study will follow for five years post-consent.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Natural History of Parkinson's Disease-associated Spinal Disorders
    Actual Study Start Date :
    Feb 14, 2019
    Anticipated Primary Completion Date :
    Feb 14, 2025
    Anticipated Study Completion Date :
    Feb 14, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Natural history of spine disorders in idiopathic Parkinson's disease [Consent to five years]

      Natural history of spine disorders in idiopathic Parkinson's disease

    Secondary Outcome Measures

    1. Clinical impact of Parkinson's related spinal disorders [Consent to five years]

      Clinical impact of Parkinson's related spinal disorders assessed by radiographic imaging and biodynamic testing

    2. Factors associated with the development and progression of Parkinson's related spinal disorders [consent to five years]

      Factors associated with the development and progression of Parkinson's related spinal disorders by assessing patients reported outcomes

    3. Parameters for optimal management [consent to five years]

      Parameters for optimal management will be assessed by imaging and patient's medical records

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75
    Exclusion Criteria:
    • Prior spinal fusion Diagnosis of ankylosing spondylitis, diffuse idiopathic spinal hyperostosis (DISH), or other systemic condition that affects spinal function Inability to consent Current incarceration Presence of other medical condition or neurologic condition that would hinder ability to perform biodynamic testing

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ohio State University Columbus Ohio United States 43210

    Sponsors and Collaborators

    • Ohio State University

    Investigators

    • Principal Investigator: Andrew Grossbach, MD, Ohio State University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew Grossbach, Associate Attending, Ohio State University
    ClinicalTrials.gov Identifier:
    NCT04101513
    Other Study ID Numbers:
    • 2018H0580
    First Posted:
    Sep 24, 2019
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Spinal Diseases
    Parkinson Disease

    Study Results

    No Results Posted as of Sep 16, 2021