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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's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS Evaluation phase
Subject is willing and able to attend all study-required visits and complete the study procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 1.5 years
Awards & highlights

ADAPT-PD Trial 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.Check my eligibility
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.See study design
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.

ADAPT-PD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My deep brain stimulation settings and Parkinson's medications will not change during the study.
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I can attend all required study visits and complete the procedures.
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I have Medtronic DBS leads in my brain for Parkinson's or dystonia.
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My doctor thinks I respond well to DBS Therapy.
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I am a man or a woman not currently pregnant. If I can have children, I use or agree to use birth control.
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I have been diagnosed with Parkinson's disease.

ADAPT-PD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 1.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 1.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
On time without troublesome dyskinesia
Secondary outcome measures
Stimulation energy use
Other outcome measures
Safety (SAEs, AEs and DDs)
Safety (Stimulation-related AEs)

ADAPT-PD 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 DualThreshold Mode

Find a Location

Who is running the clinical trial?

MedtronicNeuroLead Sponsor
69 Previous Clinical Trials
20,734 Total Patients Enrolled
Helen Bronte-Stewart, MD, MSEPrincipal InvestigatorStanford University

Media Library

Adaptive DBS (Deep Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT04547712 — N/A
Parkinson's Disease Research Study Groups: aDBS Single Threshold, aDBS Dual Threshold
Parkinson's Disease Clinical Trial 2023: Adaptive DBS Highlights & Side Effects. Trial Name: NCT04547712 — N/A
Adaptive DBS (Deep Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04547712 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any outposts carrying out this research project within the state's borders?

"This clinical trial has many sites across the United States, such as Duke University in Durham, North carolina, University of Florida in Gainesville, Florida and Vanderbilt University Medical Center in Nashville Tennessee. There are 8 other locations also taking part."

Answered by AI

Is it currently possible to register for this experiment?

"Clinicaltrials.gov states that this medical study is no longer recruiting candidates; the trial was first posted on December 14th 2020 and had its last update November 11th 2022. Despite not actively enrolling, there are 488 other clinical trials currently accepting patients."

Answered by AI
~20 spots leftby Apr 2025