Longitudinal Outcomes of DBS in PD
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 8/15/2018 |
| Start Date: | August 9, 2018 |
| End Date: | December 31, 2021 |
| Contact: | Nicole Jones |
| Email: | nicole.k.jones@vumc.org |
| Phone: | 615-936-1229 |
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.
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.
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- unable to complete study assessments
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Principal Investigator: David A Isaacs, MD
Phone: 615-936-1229
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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