DBS Stimulation Patterns for Parkinson's Disease
Trial Summary
What is the purpose of this trial?
This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with Parkinson's disease (PD) being treated with Deep Brain Stimulation (DBS) through the Medtronic Percept PC DBS device. The investigators hypothesize that stimulation patterns designed to better target excessive synchrony in a patient-tailored manner may result in more efficient and effective therapy with fewer side effects. Medtronic 3rd-generation sensing implantable neural stimulator, Percept PC, is FDA-approved for treating PD. The Percept PC device features BrainSense, the first and only available sensing technology for deep brain stimulation. BrainSense technology allows the device to capture and record brain signals (local field potentials, or LFP) using the brain-implanted DBS lead, while simultaneously delivering therapeutic stimulation. Investigators plan to enroll and complete investigations in 15 study subjects total, who have been previously implanted with the Medtronic Percept PC for the treatment of PD, and who are optimized for clinical stimulation and anti-Parkinsons medication. Investigations will be performed in UNMC Movement Disorders Clinic, UNMC Neurosurgery Lab, and UNO Biomechanics Research Building, Gait Lab. Subjects will receive research stimulation patterns and the effect on PD motor symptoms will be assessed via Unified Parkinsons Disease Rating Scale (UPDRS)-part III and gait measures. Videotaping of patient UPDRS-III testing and gait will be obtained.
Do I need to stop my current medications for this trial?
The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should be optimized for clinical stimulation and anti-Parkinson's medication for at least 3 months post-surgery, suggesting that you may continue your current medications.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop your current medications. However, it mentions that participants should be optimized for clinical stimulation and anti-Parkinson's medication, suggesting you may continue your current treatment.
What data supports the idea that DBS Stimulation Patterns for Parkinson's Disease is an effective treatment?
The available research shows that DBS Stimulation Patterns for Parkinson's Disease is effective in improving motor function in patients with advanced Parkinson's disease. It is considered the treatment of choice for advanced cases and is also being used in early stages of the disease. Studies have shown that DBS helps patients manage the negative effects of other treatments and treatment failures. While its impact on sleep is less clear, the overall improvement in motor function is well-documented.12345
What data supports the effectiveness of the treatment Novel DBS stimulation patterns, Deep Brain Stimulation, DBS, Percept PC DBS, Medtronic Percept PC for Parkinson's Disease?
Research shows that deep brain stimulation (DBS) is a well-established treatment for improving motor function in advanced Parkinson's disease. The Medtronic Percept PC device, which is part of this treatment, is notable for its ability to record brain signals during stimulation, potentially enhancing its effectiveness.12345
What safety data is available for DBS treatment for Parkinson's Disease?
The safety data for DBS treatment, including devices like Medtronic Percept PC, shows that common complications include infections (16.2%), lead migrations (8.6%), circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%), and device-related trauma (4.5%). Over 40% of devices with adverse events required surgical intervention for explant or revision. Further research is needed to reduce infection rates and device malfunctions.56789
Is deep brain stimulation (DBS) generally safe for humans?
Is the treatment Novel DBS stimulation patterns a promising treatment for Parkinson's Disease?
How is the Novel DBS stimulation pattern treatment different from other treatments for Parkinson's disease?
The Novel DBS stimulation patterns, including Temporally Optimized Patterned Stimulation (TOPS), offer a new way to personalize deep brain stimulation by adjusting the timing of the electrical pulses. This approach may improve symptom relief and energy efficiency compared to standard DBS, making it a unique option for managing Parkinson's disease symptoms.23101112
Research Team
Aviva Abosch, MD, PhD
Principal Investigator
University of Nebraska
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive novel DBS stimulation patterns and are assessed for motor symptoms and side effects
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Novel DBS stimulation patterns
Novel DBS stimulation patterns is already approved in United States, European Union for the following indications:
- Parkinson's disease
- Essential tremor
- Epilepsy
- Dystonia
- Obsessive-compulsive disorder
- Parkinson's disease
- Essential tremor
- Epilepsy
- Dystonia
- Obsessive-compulsive disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Nebraska
Lead Sponsor