NL-OMON46916CompletedNot 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 enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 4
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
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
Investigators
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