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Device
DBS Stimulation Patterns for Parkinson's Disease
N/A
Recruiting
Led By Aviva Abosch, MD, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Significant stimulation-induced side effects
Not willing to participate in the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up years 1-2
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether different stimulation patterns may be more efficient and effective in treating Parkinson's disease, with fewer side effects.
Who is the study for?
This trial is for Parkinson's Disease patients who have already had a specific brain stimulation device (Medtronic Percept PC) implanted and are responding well to treatment. They must consent to participate, have detectable brain signal patterns, be at least 3 months post-surgery, and optimized on their current therapy.
What is being tested?
The study tests new stimulation patterns from the Medtronic Percept PC DBS device against standard ones in treating Parkinson's. It aims to see if these novel patterns can improve symptoms more effectively with fewer side effects.
What are the potential side effects?
While not explicitly listed, potential side effects may include those typically associated with DBS adjustments such as speech problems, balance issues, tingling sensations or muscle contractions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I experience severe side effects from my treatment.
Select...
I am not willing to participate in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ years 1-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~years 1-2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability of novel DBS stimulation patterns.
Secondary study objectives
Response to novel DBS stimulation patterns.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: PD with DBSExperimental Treatment1 Intervention
Patients with Parkinson's Disease who were implanted with Medtronic Percept PC for DBS and consent to participate in the study.
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Who is running the clinical trial?
University of NebraskaLead Sponsor
555 Previous Clinical Trials
1,145,374 Total Patients Enrolled
Aviva Abosch, MD, PhD2.76 ReviewsPrincipal Investigator - University of Nebraska
University of Nebraska
3 Previous Clinical Trials
101 Total Patients Enrolled
5Patient Review
My lobectomy was handled with great care by Dr. Abosch and her team. I was in the hospital for 21 days, and they made sure to keep me and my husband informed and comfortable every step of the way. I'm still curious to know what they learn from my temporal lobe, but I'm grateful for the excellent care I received. We always recommend the University of Colorado to others looking for great doctors.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on medication and clinical stimulation for 3 months after my DBS system surgery.You need frequent changes to your treatment plan or device settings.I experience severe side effects from my treatment.You have had surgery to implant devices in both sides of your brain and a specific type of neural stimulator.I am not willing to participate in the study.The patient's Medtronic Percept TM PC indicates that the device needs to be replaced soon.You have a strong beta peak measured during surgery.My condition improved by 30% after surgery, 3 months ago.I am recommended for deep brain stimulation for my Parkinson's Disease.You require special settings for the device that are either very high or very low frequencies.
Research Study Groups:
This trial has the following groups:- Group 1: PD with DBS
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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