Parkinson DiseaseNCT04101513
The Natural History of Parkinson's Disease-associated Spinal Disorders
An observational study of Parkinson Disease and Idiopathic Parkinson Disease, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson Disease, Idiopathic Parkinson Disease
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2019to 14 Feb 2027
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Parkinson's patients in their early to mid-disease state. (Hoehn and Yahr scale 1-3) Age 18-75 years
Who may be able to join
- Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural history of spine disorders in idiopathic Parkinson's disease
Natural history of spine disorders in idiopathic Parkinson's disease
Measured: Consent to five years
Secondary outcomes (3)
Clinical impact of Parkinson's related spinal disorders
Clinical impact of Parkinson's related spinal disorders assessed by radiographic imaging and biodynamic testing
Measured: Consent to five years
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
Measured: consent to five years
Parameters for optimal management
Parameters for optimal management will be assessed by imaging and patient's medical records
Measured: consent to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start14 Feb 2019
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Feb 2027 (estimated)
Why it stopped: Since this project enrolls early-stage Parkinson's patients we hope to develop a registry style study that will allow us to study the progression of spinal disorders in Parkinson patients more effectively.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Grossbach, Ohio State University
- Investigators
- Andrew Grossbach, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101513
- Sponsor's protocol ID
- 2018H0580
- Status last verified
- May 2023
- First submitted
- 23 Sep 2019
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural History of Parkinson's Disease-associated Spinal Disorders
- ClinicalTrials.gov ID
- NCT04101513
- Acronym / sponsor ID
- 2018H0580
- Conditions
- Parkinson Disease, Idiopathic Parkinson Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Since this project enrolls early-stage Parkinson's patients we hope to develop a registry style study that will allow us to study the progression of spinal disorders in Parkinson patients more effectively.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 14 Feb 2019 (actual)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Feb 2027 (estimated)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients in their early to mid-disease state. (Hoehn and Yahr scale 1-3) Age 18-75 years
Key inclusion criteria (1 listed)
- Diagnosis of Idiopathic Parkinson Disease Early to mid-disease course (Hoehn and Yahr scale 1-3) Age 18-75
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Natural history of spine disorders in idiopathic Parkinson's disease
Time frame: Consent to five years
Natural history of spine disorders in idiopathic Parkinson's disease
3 secondary outcomes
Clinical impact of Parkinson's related spinal disorders
Time frame: Consent to five years
Factors associated with the development and progression of Parkinson's related spinal disorders
Time frame: consent to five years
Parameters for optimal management
Time frame: consent to five years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Grossbach, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Idiopathic Parkinson Disease, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of spine disorders in idiopathic Parkinson's disease (time frame: Consent to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.