NCT04101513

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
9mo left

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
Feb 2019Feb 2027

Study Start

First participant enrolled

February 14, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 14, 2027

Expected
Last Updated

May 12, 2023

Status Verified

May 1, 2023

Enrollment Period

6 years

First QC Date

September 23, 2019

Last Update Submit

May 10, 2023

Conditions

Parkinson DiseaseIdiopathic Parkinson Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Clinical impact of Parkinson's related spinal disorders

    Consent to five years

  • Factors associated with the development and progression of Parkinson's related spinal disorders

    consent to five years

  • Parameters for optimal management

    consent to five years

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's patients in their early to mid-disease state. (Hoehn and Yahr scale 1-3) Age 18-75 years

You may qualify if:

  • Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Andrew Grossbach, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Attending

Study Record Dates

First Submitted

September 23, 2019

First Posted

September 24, 2019

Study Start

February 14, 2019

Primary Completion

February 14, 2025

Study Completion (Estimated)

February 14, 2027

Last Updated

May 12, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)