Adaptive DBS for Parkinson's Disease
(ADAPT-PD Trial)
Recruiting at 11 trial locations
AT
Overseen ByADAPT-PD Trial Clinical Research Team
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: MedtronicNeuro
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
Research Team
HB
Helen M Bronte-Stewart, MD MSE
Principal Investigator
Stanford University
Eligibility Criteria
This trial is for adults with stable Parkinson's disease who respond to DBS therapy, can attend all study visits, and are not pregnant. They must use specific Medtronic DBS leads and have detectable Beta band amplitude in their brain signals. Excluded are those under 18, breastfeeding women, individuals with multiple brain implants or enrolled in other studies that could affect results.Inclusion Criteria
My deep brain stimulation settings and Parkinson's medications will not change during the study.
I can attend all required study visits and complete the procedures.
The participant is set up to use a specific type of stimulation on at least one side.
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Exclusion Criteria
I am under 18 years old.
Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team
Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
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Treatment Details
Interventions
- Adaptive DBS (Deep Brain Stimulation)
Trial OverviewThe study tests the safety and effectiveness of adaptive Deep Brain Stimulation (aDBS) for Parkinson's patients. It involves using aDBS technology tailored to individual patient responses compared to standard settings while monitoring its impact on Parkinson's symptoms.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: aDBS Single ThresholdExperimental Treatment1 Intervention
Adaptive DBS Single Threshold Mode
Group II: aDBS Dual ThresholdExperimental Treatment1 Intervention
Adaptive DBS Dual Threshold Mode
Adaptive DBS is already approved in Canada for the following indications:
Approved in Canada as DBS Therapy for Parkinson's Disease for:
- Treatment of disabling motor symptoms of recent and longer-standing Parkinson's disease, essential tremor, and epilepsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
MedtronicNeuro
Lead Sponsor
Trials
72
Recruited
20,900+
Geoff Martha
MedtronicNeuro
Chief Executive Officer since 2020
Finance degree from Penn State University
Dr. Eric Peterson
MedtronicNeuro
Chief Medical Officer since 2020
MD from University of Miami