NL-OMON46916
Completed
Not Applicable
Directional Lead: Investigation of Rotational Current Steering, Ease of Use of Clinical Effects Map, and Therapeutic Outcomes of Deep Brain Stimulation - DIRECT-DBS
Boston Scientific Cooperation International0 sites4 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Boston Scientific Cooperation International
- Enrollment
- 4
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •IC1\. Candidate for Vercise\* PC DBS with bilateral implant of BSN DBS Directional Leads in STN, and meets:
- •Diagnosis of bilateral idiopathic PD with the presence of rigidity and at least one (1\) of the following: resting tremor or bradykinesia.
- •UPDRS III score of \>25 in the meds OFF condition
- •Medication must improve PD symptoms by \>\=30%, as measured by UPDRS subset III score
- •IC2\. Willing and able to comply with all visits, including required travel, and with study related procedures
- •IC3\. Meets all requirements of Vercise\* PC Local Directions For Use (DFU)
- •IC4\. Able to understand the study requirements and the treatment procedures and provides written informed consent before any study\-specific tests or procedures are performed
Exclusion Criteria
- •EC1\. Any significant psychiatric problems, including unrelated clinically significant depression as determined by the investigator
- •EC2\. Any current drug or alcohol abuse as determined by the investigator
- •EC3\. Any history of recurrent or unprovoked seizures
- •EC4\. Any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months
Outcomes
Primary Outcomes
Not specified
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