Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation
Brief summary
The purpose of the study is to document patient outcomes including effectiveness for Boston Scientific Corporation's Vercise Cartesia 16-contact Directional Lead(s) (X/HX) with Deep Brain Stimulation (DBS) systems for the treatment of Parkinson's Disease (PD).
Detailed description
Subjects will receive Deep Brain Stimulation with a 16-contact Directional Lead to treat their Parkinson's Disease.
Interventions
DEVICE16-contact Directional Deep Brain Stimulation
Deep Brain Stimulation with 16-contact Directional Lead
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Candidate for DBS implant in the treatment of Parkinson's disease * Must be on stable anti-parkinsonian medications for 28 days prior to Informed Consent * Persistent disabling Parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling off periods despite optimal medical therapy * Be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.). Key
Exclusion criteria
* Any intracranial abnormality or medical condition that would contraindicate DBS surgery * Have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster B personality disorders) * Any current drug or alcohol abuse, as determined by the investigator * Any history of recurrent or unprovoked seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Function | 12 weeks post device-activation | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Function | 26 weeks post device-activation | Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function. |
| Change in Quality of Life | 12 weeks post device-activation | Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health. |
Countries
Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 16-contact Directional Deep Brain Stimulation Deep Brain Stimulation with a 16-contact Directional Lead
16-contact Directional Deep Brain Stimulation: Deep Brain Stimulation with 16-contact Directional Lead | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Screen Failure | 7 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | 16-contact Directional Deep Brain Stimulation |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 6.7 |
| MDS-UPDRS-III score (meds off condition) | 47.9 units on a scale STANDARD_DEVIATION 12.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 3 Participants |
| Race (NIH/OMB) White | 44 Participants |
| Region of Enrollment Germany | 22 participants |
| Region of Enrollment Netherlands | 17 participants |
| Region of Enrollment United Kingdom | 10 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 58 |
| other Total, other adverse events | 25 / 58 |
| serious Total, serious adverse events | 14 / 58 |
Outcome results
Primary
Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline in meds off condition to 12 weeks post device-activation in stim on/meds off condition. Range 0 - 108. Higher scores indicate worse function.
Time frame: 12 weeks post device-activation
Population: Intent to treat population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Motor Function | -19.9 units on a scale | Standard Deviation 12.8 |
Secondary
Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 26 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Time frame: 26 weeks post device-activation
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Motor Function | -21.4 units on a scale | Standard Deviation 11.9 |
Secondary
Change in Motor Function
Mean change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores from Baseline (meds off) to 52 weeks post device-activation (stim on/meds off). Range 0 - 108. Higher scores indicate worse function.
Time frame: 52 weeks post device-activation
Population: Intent to treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Motor Function | -21.2 score on a scale | Standard Deviation 14 |
Secondary
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 12 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Time frame: 12 weeks post device-activation
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Quality of Life | -6.1 units on a scale | Standard Deviation 11 |
Secondary
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 26 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Time frame: 26 weeks post device-activation
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Quality of Life | -5.3 units on a scale | Standard Deviation 11.4 |
Secondary
Change in Quality of Life
Mean change in Parkinson's Disease Questionnaire (PDQ-39) summary scores from Baseline (meds on) to 52 weeks post device-activation (stim on/meds on). Scores range from 0 to 100, with 0 representing perfect health and 100 representing worst health.
Time frame: 52 weeks post device-activation
Population: Intent to Treat population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16-contact Directional Deep Brain Stimulation | Change in Quality of Life | -6.4 units on a scale | Standard Deviation 11.5 |