Parkinson's Disease (PD)
Conditions
Brief summary
The study will explore the viability of an alternative/novel programming strategy in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Detailed description
The study will explore the feasibility of utilizing an alternative/novel programming technique in Deep Brain Stimulation (DBS) for patients with Parkinson's Disease (PD).
Interventions
DEVICEConventional Programming (cDBS)
The commercial CP installed with commercial software will be used to set up standard cDBS therapy on the IPG.
DEVICENovel Programming (nDBS)
The commercial CP installed with the investigational DBS programming software will be used to set up Novel Programming (nDBS) therapy on the IPG.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
During follow-up, the conventional Deep Brain Stimulation (cDBS) program and one or more of these novel Deep Brain Stimulation (nDBS) programs are programmed into a subject's IPG. At the investigator's discretion, a copy of the cDBS program may also be stored in one of the investigational slots. The subject will be blinded to the slot number assignment for the cDBS program.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Subject with PD implanted bilaterally in the STN and receiving DBS therapy for at least 3 months. 2. Tolerates \> 12 hours OFF medication and, per clinical judgment, be able to perform all study related procedures. 3. Able to understand the study requirements and the treatment procedures and must provide written informed consent before any study-specific tests or procedures are performed. Key
Exclusion criteria
1. Exhibits significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator. 2. A female who is pregnant, is breastfeeding, or is of childbearing potential and planning to get pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Quality of Life using new programming paradigm: PDQ-39 | approximately 4 weeks | Change in Parkinson's Disease Questionnaire (PDQ-39) summary index and sub-scores |
Countries
Germany
Outcome results
None listed