Parkinson DiseaseNCT03582163
Longitudinal Outcomes of DBS in PD
An observational study of Parkinson Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2018to 31 Dec 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The primary study base consists of all patients with Parkinson's disease 2 years or more status post DBS implantation at Vanderbilt University Medical Center.
Who may be able to join
- diagnosis of Parkinson's disease
- status post deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) or globus pallidus interna (GPi) at Vanderbilt University Medical Center
Who cannot join
- unable to complete study assessments
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Longitudinal Outcomes of Deep Brain Stimulation in Parkinson's Disease
Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. This information is stored in RedCAP, a secure online database platform. In an attempt to capture longitudinal outcomes in this population of interest, we will recruit all PD patients two years or more status post DBS who are receiving regular care at Vanderbilt University Medical Center. Study participants will undergo a condensed evaluation of motor function (Unified Parkinson's Disease Rating Scale Part III), cognitive performance (Mini-Mental Status Examination), mood (Beck Depression Inventory), and quality of life (Parkinson's Disease Questionnaire-39). These results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. STN and GPi DBS patients will be analyzed separately.
Read the detailed description
Patients will be recruited from review of movement disorders neurologists' outpatient census. All patients with PD two or more years status post DBS will be contacted via phone and/or mailed letter. Any interested patient will be mailed or e-mailed (via RedCAP) a copy of the study informed consent form. Willing patients will present to the Vanderbilt Movement Disorders Clinic for an opportunity to inquire further about the study and sign the informed consent form in person.
Participants will have a single study visit, ideally coordinated with their regularly scheduled neurology follow-up. During the study visit, the following evaluations will be performed by a trained research assistant:
Video-recorded UPDRS III BDI MMSE PDQ-39 In addition, current PD medications and number of falls in the past 6 months will be recorded. Assessments will occur in the on-medication, on-DBS state.
The video-recorded UPDRS III will be reviewed and score at a subsequent date by a blinded rater (movement discord trained neurologist).
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Longitudinal Outcomes, Subthalamic Nucleus, Globus Pallidus Interna
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| STN | Patients with Parkinson's disease who have undergone subthalamic nucleus (STN) DBS. | |
| GPi | Patients with Parkinson's disease who have undergone GPi (GPi) DBS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale, Part III (UPDRS III)
Parkinson's disease motor assessment
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start9 Aug 2018
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Why it stopped: Recruitment and enrollment were significantly slowed during the COVID-19 pandemic, and then research team effort shifted to another initiatives in interim.
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 Vanderbilt University Medical CenterThe 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
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Isaacs, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582163
- Sponsor's protocol ID
- VUMCLODBSPD
- Status last verified
- Mar 2025
- First submitted
- 27 Jun 2018
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Outcomes of Deep Brain Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03582163
- Acronym / sponsor ID
- VUMCLODBSPD
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Longitudinal Outcomes, Subthalamic Nucleus, Globus Pallidus Interna
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment and enrollment were significantly slowed during the COVID-19 pandemic, and then research team effort shifted to another initiatives in interim.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 9 Aug 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Jul 2018 (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.
Vanderbilt University Medical Center is one of the largest-volume DBS centers in the country. From 2007 through October 2017, 265 Parkinson's disease (PD) patients underwent deep brain stimulation (DBS), 168 of those implanted in subthalamic nucleus (STN) and 97 in globus pallidus interna (GPi). Pre-operatively, each patient is extensively evaluated with a battery of validated motor, cognitive, and mood instruments. This information is stored in RedCAP, a secure online database platform. In an attempt to capture longitudinal outcomes in this population of interest, we will recruit all PD patients two years or more status post DBS who are receiving regular care at Vanderbilt University Medical Center. Study participants will undergo a condensed evaluation of motor function (Unified Parkinson's Disease Rating Scale Part III), cognitive performance (Mini-Mental Status Examination), mood (Beck Depression Inventory), and quality of life (Parkinson's Disease Questionnaire-39). These results will be compared to baseline measures performed pre-operatively, allowing for assessment of interval change. STN and GPi DBS patients will be analyzed separately.
Detailed description
Patients will be recruited from review of movement disorders neurologists' outpatient census. All patients with PD two or more years status post DBS will be contacted via phone and/or mailed letter. Any interested patient will be mailed or e-mailed (via RedCAP) a copy of the study informed consent form. Willing patients will present to the Vanderbilt Movement Disorders Clinic for an opportunity to inquire further about the study and sign the informed consent form in person.
Participants will have a single study visit, ideally coordinated with their regularly scheduled neurology follow-up. During the study visit, the following evaluations will be performed by a trained research assistant:
Video-recorded UPDRS III BDI MMSE PDQ-39 In addition, current PD medications and number of falls in the past 6 months will be recorded. Assessments will occur in the on-medication, on-DBS state.
The video-recorded UPDRS III will be reviewed and score at a subsequent date by a blinded rater (movement discord trained neurologist).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STN | – | –Patients with Parkinson's disease who have undergone subthalamic nucleus (STN) DBS. |
| GPi | – | –Patients with Parkinson's disease who have undergone GPi (GPi) DBS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The primary study base consists of all patients with Parkinson's disease 2 years or more status post DBS implantation at Vanderbilt University Medical Center.
Key inclusion criteria (2 listed)
- diagnosis of Parkinson's disease
- status post deep brain stimulation (DBS) implantation in the subthalamic nucleus (STN) or globus pallidus interna (GPi) at Vanderbilt University Medical Center
Key exclusion criteria (1 listed)
- unable to complete study assessments
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
Unified Parkinson's Disease Rating Scale, Part III (UPDRS III)
Time frame: at least 2 years
Parkinson's disease motor assessment
Results and safety
The study was stopped early (reason given: Recruitment and enrollment were significantly slowed during the COVID-19 pandemic, and then research team effort shifted to another initiatives in interim.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Vanderbilt University Medical Center 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 2 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: stopped early, as of the sponsor's last update on 14 Mar 2025. 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 stopped early (reason given: Recruitment and enrollment were significantly slowed during the COVID-19 pandemic, and then research team effort shifted to another initiatives in interim.). Results are not available in the source record.
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?
Unified Parkinson's Disease Rating Scale, Part III (UPDRS III) (time frame: at least 2 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 14 Mar 2025.