Phase
Condition
N/ATreatment
CereGate Software; BSN cDBS Programmer; BSN Burst Programmer
Clinical Study ID
Ages 21-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant has an implanted STN-DBS system with Boston Scientific Gevia™ or Genus™R16 IPG connected to any brand lead or extension that have been approved by the FDAto be used with Gevia or Genus IPGs.
Participant is receiving treatment with carbidopa/levodopa, and/or with a dopamineagonist at the optimal doses as determined by a movement disorders neurologist.
DBS optimized with documented improvement in motor signs (UPDRSIII) from DBS
Exclusion
Exclusion Criteria:
Participant is unable to understand the study requirements and the treatmentprocedures, or unwilling / unable to provide written informed consent before anystudy-specific tests or procedures are performed.
Participant is unwilling or unable to comply with visit schedule and study relatedprocedures.
Participant's medication regimen has not been stable for at least 28 days prior toCG initiation.
Participant's DBS stimulation settings have not been stable for at least 28 daysprior to CG initiation.
Participant is less than 21 years of age or older than 80 years of age.
Participant is a female who is breastfeeding or of child-bearing potential with apositive urine pregnancy test or not using adequate contraception as determined bythe study investigator.
Participant has a terminal illness with life expectancy of < 1 year.
Participant has history of recurrent or unprovoked seizures.
Participant currently diagnosed with drug or alcohol abuse, per DSM-5 criteria.
Participant is in a very advanced stage of Parkinson's disease defined as: (i) Stage 5 as classified by the Hoehn and Yahr scale on medication and DBS (non-ambulatory)or (ii) participant requires an assistive device to perform the TBC OFF-meds /ON-DBSat the time of enrollment.
Participant has a condition that makes walking difficult or could interfere with thestudy procedures or confound the evaluation of the study data, includingmusculoskeletal issues, peripheral neuropathies, hip/knee prostheses, or any visualor anatomical abnormality that affects their walking.
Participant has disabling dyskinesias.
Participant has a history of suicide attempt or current active suicidal ideation asdetermined by a positive response to Items 2-5 of suicide ideation sub-scale of theColumbia Suicide Severity Rating Scale (CSSRS).
Participant, at the time of enrollment, fails the subthalamic nucleus (STN)stimulation challenge test (subject must perceive distinct bilateral sensations).
Participant has less than 8% arrhythmicity as measured in the Turning and BarrierCourse Figures of 8 (TBC-F8) pre-CG therapy (ON Medications/ON DBS /OFF CG).
Study Design
Study Description
Connect with a study center
St. Joseph's Hospital and Medical Center: Barrow Neurological Institute
Phoenix, Arizona 85013
United StatesSite Not Available
Cedars Sinai Neurology
Los Angeles, California 90048
United StatesActive - Recruiting
Kaiser Permanente, KPNC Comprehensive Movement Disorders Program
Redwood City, California 94063
United StatesActive - Recruiting
Stanford University School of Medicine, Center for Academic Medicine
Stanford, California 94305
United StatesSite Not Available
University of Colorado Anschutz Medical Campus
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
Northwestern University
Chicago, Illinois 60611
United StatesActive - Recruiting
Wake Forest University
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
University of Washington
Seattle, Washington 98195
United StatesActive - Recruiting
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