Coordinated Reset Deep Brain Stimulation

Launched by BOSTON SCIENTIFIC CORPORATION · Nov 6, 2018

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to use Deep Brain Stimulation (DBS) for people with Parkinson's Disease (PD). DBS is a treatment where a small device is implanted in the brain to help control movement and reduce symptoms of PD. The study aims to test a different programming method for this device to see if it can improve outcomes for patients.

To be eligible for this trial, participants must have had DBS therapy for at least three months and be able to go without their PD medication for more than 12 hours. They also need to understand the study procedures and provide written consent. Unfortunately, individuals with significant mental health issues or those who are pregnant, breastfeeding, or planning to become pregnant cannot participate. If you join the study, you can expect to undergo various tests and procedures related to the new programming strategy, which may help improve your treatment experience.

Gender

ALL

Eligibility 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