Parkinson Disease
Conditions
Keywords
parkinson disease, deep brain stimulation, directional stimulation
Brief summary
The primary objective is to characterize the programming effects of Boston Scientific Vercise™ PC System using the DBS Directional Lead for bilateral STN DBS for the treatment of Parkinson's disease in acute and chronic settings.
Interventions
DEVICEBSC Deep Brain Stimulation System with Directional Lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1) of the following: resting tremor or bradykinesia. * UPDRS III score of \>25 in the meds OFF condition * Medication must improve PD symptoms by ≥30%, as measured by UPDRS subset III score Key
Exclusion criteria
* Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator * Any current drug or alcohol abuse as determined by the investigator * Any history of recurrent or unprovoked seizures * Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Up to 12 months post-implant | Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state |
Countries
France, Germany, Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ring Mode Followed by Unrestricted Mode omni-directional stimulation followed by unrestricted Mode stimulation
BSC Deep Brain Stimulation System with Directional Lead | 6 |
| Unrestricted Mode Followed by Ring Mode Unrestricted Mode stimulation followed by omni-directional stimulation
BSC Deep Brain Stimulation System with Directional Lead | 6 |
| Total | 12 |
Baseline characteristics
| Characteristic | Ring Mode Followed by Unrestricted Mode | Unrestricted Mode Followed by Ring Mode | Total |
|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 6 | 63.4 years STANDARD_DEVIATION 7.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase
Mean change in Unified Parkinson's Disease Rating Scale (UPDRS) scores - motor section (Part III) at end of randomized phase in meds ON condition Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state
Time frame: Up to 12 months post-implant
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ring Mode | Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Baseline | 21 units on a scale | Standard Deviation 11 |
| Ring Mode | Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | End of Randomized Phase | 13 units on a scale | Standard Deviation 8 |
| Unrestricted Mode | Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | Baseline | 21 units on a scale | Standard Deviation 11 |
| Unrestricted Mode | Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS) Scores - Motor Section (Part III) at End of Randomized Phase | End of Randomized Phase | 16 units on a scale | Standard Deviation 10 |