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

Withdrawn

• Conditions: Parkinson Disease; Idiopathic Parkinson Disease

• Registration Number: NCT04101513
• Lead Sponsor: Ohio State University

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.

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 Timeline

• Study Start: 2019-02-14
• Study First Submitted: 2019-09-23
• Study First Submitted QC: 2019-09-23
• Study First Posted: 2019-09-24
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-12
• Primary Completion: 2025-02-14
• Study Completion: 2027-02-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Parameters for optimal management	consent to five years	Parameters for optimal management will be assessed by imaging and patient's medical records
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

Trial Locations

Locations (1)

Ohio State University; 🇺🇸 Columbus, Ohio, United States