Dystonia-Parkinsonism, Adult-Onset, Parkinson Disease
Conditions
Keywords
Dystonia, Parkinson's Disease
Brief summary
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.
Detailed description
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.
Interventions
We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
Sponsors
Michael J. Fox Foundation for Parkinson's Research
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
This study will run in conjunction with Biomarkers to Guide Directional DBS for Parkinson's Disease (ClinicalTrials.gov Identifier: NCT03353688). It is a double blinded study investigating the effectiveness of directional DBS leads in which participants and some investigators will have no knowledge of the DBS settings participants experience.
Intervention model description
To measure the effects of directional DBS on dystonia, we will measure the change in the Burke-Fahn-Marsden Dystonia Rating Scale at 2, 4, 6, and 12 months after surgery versus preoperative baseline
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Enrollment in Biomarkers to Guide Directional DBS for Parkinson's Disease (ClinicalTrials.gov Identifier: NCT03353688) * Diagnosis of Parkinson's disease with and without dystonia
Exclusion criteria
* Not enrolled in Biomarkers to Guide Directional DBS for Parkinson's Disease (ClinicalTrials.gov Identifier: NCT03353688)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burke-Fahn-Marsden Dystonia Rating Scale | 5 minutes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
All subjects provided written informed consent prior to participation with approval from the institutional review board. We included data from all consecutively enrolled participants. Dystonia status was not part of the enrollment criteria.
Participants by arm
| Arm | Count |
|---|---|
| Study Patients Enrolled in Study All patients enrolled in the study | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Study Patients Enrolled in Study |
|---|---|
| Age, Continuous | 49.0 years STANDARD_DEVIATION 13.2 |
| Burke-Fahn-Marsden Total Dystonia Scale | 3.5 units on a scale STANDARD_DEVIATION 6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 38 |
| other Total, other adverse events | 0 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
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
Population: We analyzed data from all enrolled participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Patients Enrolled in Study | Burke-Fahn-Marsden Dystonia Rating Scale | 3.5 units on a scale | Standard Deviation 6 |
Comparison: We tested the equivalence of Burke-Fahn-Marsden scores over time (at baseline and at two time periods following DBS surgery) using a repeated measures ANOVA.p-value: <0.001linear mixed effects model