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Deep Brain Stimulation
Adaptive DBS for Parkinson's Disease (ADAPT-PD Trial)
N/A
Waitlist Available
Led By Helen Bronte-Stewart, MD, MSE
Research Sponsored by MedtronicNeuro
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is implanted with specific Medtronic DBS leads and extensions bilaterally in the same target (physician confirmed), STN or GPi
Subject has idiopathic Parkinson's disease
Must not have
Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
Subject is under the age of 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 1.5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will show if aDBS is safe and effective for treating Parkinson's disease.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the stimulation site, headache, dizziness, involuntary movements or worsening of Parkinson’s symptoms due to stimulation adjustments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have Medtronic DBS leads in my brain for Parkinson's or dystonia.
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I have been diagnosed with Parkinson's disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I need treatments like diathermy, TMS, or ECT for my condition.
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I am under 18 years old.
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I cannot use or tolerate wearable devices.
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I have or plan to get a pump implanted for Parkinson's treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, approximately 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1.5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
On time without troublesome dyskinesia
Secondary study objectives
Stimulation energy use
Other study objectives
Safety (SAEs, AEs and DDs)
Safety (Stimulation-related AEs)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Find a Location
Who is running the clinical trial?
MedtronicNeuroLead Sponsor
71 Previous Clinical Trials
21,050 Total Patients Enrolled
Helen Bronte-Stewart, MD, MSEPrincipal InvestigatorStanford University
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am under 18 years old.The participant is set up to use a specific type of stimulation on at least one side.I have Medtronic DBS leads in my brain for Parkinson's or dystonia.My doctor thinks I respond well to DBS Therapy.If you are using the SenSight system, you need to have certain stimulation rates configured.I cannot use or tolerate wearable devices.I have or plan to get a pump implanted for Parkinson's treatment.People who have interference on all 6 sensing pathways of the deep brain stimulation (DBS) device, making it difficult for the doctor to adjust the settings.I am a man or a woman not currently pregnant. If I can have children, I use or agree to use birth control.I need treatments like diathermy, TMS, or ECT for my condition.I have been diagnosed with Parkinson's disease.You are receiving a certain type of electrical stimulation using specific contacts.You have certain brain wave patterns detected on specific electrodes in your brain.The device you have implanted has a battery that is expected to last less than one year.You have any extra devices in your brain that haven't been approved for this study.You are taking more than one type of insulin.You have more than one wire in each side of your brain.Your score on the Beck Depression Inventory II (BDI-II) is higher than 25.You have a metal implant in your head, like an aneurysm clip or cochlear implant.
Research Study Groups:
This trial has the following groups:- Group 1: aDBS Single Threshold
- Group 2: aDBS Dual Threshold
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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