Parkinson's Disease
Conditions
Keywords
Intrepid, Vercise, PD, DBS, Boston Scientific
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.
Detailed description
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.
Interventions
DEVICEDeep Brain Stimulation
The Vercise™ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.
Sponsors
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years. * Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling off periods) despite optimal medical therapy. * Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. Key
Exclusion criteria
* Any intracranial abnormality or medical condition that would contraindicate DBS surgery. * Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol * Any other active implanted devices including neurostimulators and /or drug delivery pumps * Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure. * Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints. * A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ON Time as Measured by Parkinson's Disease Diary | From baseline to 12 weeks post-randomization | Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Endpoints | From baseline to 12 weeks post-randomization | Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state. |
Countries
United States
Participant flow
Recruitment details
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
Pre-assignment details
Subjects were considered enrolled once informed consent was completed. Only those who met all eligibility criteria went on to receive implant and randomization for study endpoints
Participants by arm
| Arm | Count |
|---|---|
| Medium Continuous Dose of Stimulation Subjects in this arm received a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. | 121 |
| Low Intermittent Dose of Stimulation Subjects in this arm received a lower intermittent dose of Deep Brain stimulation which was less likely to be effective.
Deep Brain Stimulation: The Vercise™ DBS system was implanted in subjects in both study arms. Stimulation parameters varied depending on the study arm assignment. All subjects received therapeutic settings at the end of the blinded period. | 39 |
| Total | 160 |
Baseline characteristics
| Characteristic | Medium Continuous Dose of Stimulation | Low Intermittent Dose of Stimulation | Total |
|---|---|---|---|
| Age, Continuous Age | 60.7 years STANDARD_DEVIATION 7.9 | 57.5 years STANDARD_DEVIATION 7.66 | 59.9 years STANDARD_DEVIATION 7.9 |
| Sex: Female, Male Female | 31 Participants | 13 Participants | 44 Participants |
| Sex: Female, Male Male | 90 Participants | 26 Participants | 116 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 121 | 0 / 39 |
| other Total, other adverse events | 35 / 121 | 4 / 39 |
| serious Total, serious adverse events | 14 / 121 | 4 / 39 |
Outcome results
Primary
Change in ON Time as Measured by Parkinson's Disease Diary
Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement
Time frame: From baseline to 12 weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medium Continuous Dose of Stimulation | Change in ON Time as Measured by Parkinson's Disease Diary | 3.74 hours | Standard Deviation 4.79 |
| Low Intermittent Dose of Stimulation | Change in ON Time as Measured by Parkinson's Disease Diary | 0.72 hours | Standard Deviation 3.56 |
Secondary
Secondary Endpoints
Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization. Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state.
Time frame: From baseline to 12 weeks post-randomization
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Medium Continuous Dose of Stimulation | Secondary Endpoints | 12.02 units on a scale | Standard Deviation 11.4 |
| Low Intermittent Dose of Stimulation | Secondary Endpoints | 1.19 units on a scale | Standard Deviation 8.9 |