An interventional study of Boston Scientific Vercise PC IPG with directional DBS lead in Dystonia-Parkinsonism, Adult-Onset and Parkinson Disease, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-10.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Basic science
This study occurs during five visits that are already scheduled as part of "Biomarkers to Guide Directional DBS for Parkinson's Disease" (ClinicalTrials.gov Identifier: NCT03353688). If participants have dystonia associated with Parkinson's disease, the investigators will consent and administer one additional rating scale (Burke-Fahn-Marsden Dystonia Rating Scale) to assess the severity of dystonia.
To measure the effects of DBS on dystonia, the investigators will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline. This will allow them to contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Exclusion Criteria:
We will measure the effects of DBS on dystonia by assessing changes in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery to implant the Boston Scientific Vercise PC IPG with directional DBS lead versus preoperative baseline.
Device: Boston Scientific Vercise PC IPG with directional DBS lead
We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Burke-Fahn-Marsden Dystonia Rating Scale
Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.
Time frame: 5 minutes
Participants were recruited and studied prospectively as part of the SUNDIAL (SUbthalamic Nucleus DIrectionAL stimulation) study, a randomized, double-blind crossover study contrasting directional versus circular unilateral STN DBS for PD (FDA Investigational Device Exemption G-170063). Further details on inclusion/exclusion are outlined at https://clinicaltrials.gov/ct2/show/NCT03353688.
| Milestone | Dystonia Severity Assessment |
|---|---|
| Started | 38 |
| Completed | 38 |
| Not completed | 0 |
Evaluation of degree of dystonia related symptoms. Domains evaluated include eyes, mouth, speech/swallowing, neck, arms, trunk, and legs. Each domain is scored on degree of provoking factor (0= no dystonia at rest or with action; 4 = dystonia present at rest) and severity factor (0 = no dystonia; 4 = extreme/severe dystonia). Scores are then weighted yielding a total score between 0 and 120. Higher scores on the scale indicate greater disease severity.
| units on a scale | Study Patients Enrolled in Study |
|---|---|
| Burke-Fahn-Marsden Dystonia Rating Scale | 3.5 ± 6.0 |
Collected over 1 year from baseline visit. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dystonia Severity Assessment | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Age, Continuous(years) | Study Patients Enrolled in Study |
|---|---|
| Mean | 49.0 ± 13.2 |
| Sex: Female, Male(Participants) | Study Patients Enrolled in Study |
|---|---|
| Female | 12 |
| Male | 26 |
| Race (NIH/OMB)(Participants) | Study Patients Enrolled in Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Burke-Fahn-Marsden Total Dystonia Scale(units on a scale) | Study Patients Enrolled in Study |
|---|---|
| Mean | 3.5 ± 6.0 |
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University of Alabama at Birmingham