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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04101513
• Other study ID #: 2018H0580
• Status: Withdrawn
• Start date: February 14, 2019
• Est. completion date: February 14, 2027

Study information

• Verified date: May 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 14, 2027
• Est. primary completion date: February 14, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Idiopathic Parkinson Disease
• Parkinson Disease
• Spinal Diseases

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Natural history of spine disorders in idiopathic Parkinson's disease	Natural history of spine disorders in idiopathic Parkinson's disease	Consent to five years
Secondary	Clinical impact of Parkinson's related spinal disorders	Clinical impact of Parkinson's related spinal disorders assessed by radiographic imaging and biodynamic testing	Consent to five years
Secondary	Factors associated with the development and progression of Parkinson's related spinal disorders	Factors associated with the development and progression of Parkinson's related spinal disorders by assessing patients reported outcomes	consent to five years
Secondary	Parameters for optimal management	Parameters for optimal management will be assessed by imaging and patient's medical records	consent to five years