Exploring a new programming method for Deep Brain Stimulation in Parkinson's Disease
Coordinated Reset Deep Brain Stimulation (RESET-DBS) and RESET-DBS - Extension (Sub-study)
NA · Boston Scientific Corporation · NCT03732898
This study is testing a new way to program Deep Brain Stimulation for people with Parkinson's Disease to see if it works better than the usual methods.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Sex | All |
| Sponsor | Boston Scientific Corporation (industry) |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT03732898 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel programming strategy for Deep Brain Stimulation (DBS) in patients with Parkinson's Disease (PD). It aims to assess the feasibility of this alternative approach compared to conventional programming techniques. Participants will have been receiving DBS therapy for at least three months and will undergo evaluations to determine the effectiveness of the new programming method. The study will involve a thorough assessment of patient responses and outcomes associated with the novel programming.
Who should consider this trial
Good fit: Ideal candidates are individuals with Parkinson's Disease who have been implanted with DBS devices for at least three months and can tolerate extended periods without medication.
Not a fit: Patients with significant psychiatric issues or those who are pregnant or planning to become pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of DBS therapy for patients with Parkinson's Disease.
How similar studies have performed: While there have been various studies on DBS, this specific approach utilizing novel programming techniques is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Berlin and 1 other locations
- University Berlin, Charite Virchow — Berlin, Germany (RECRUITING)
- Universitaetsklinikum Wuerzburg — Wuerzburg, Germany (RECRUITING)
Study contacts
- Study coordinator: Cleo Mertz
- Email: BSNClinicalTrials@bsci.com
- Phone: 855-213-9890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Parkinson's Disease