DBS Stimulation Patterns for Parkinson's Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byAviva Abosch, MD, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Nebraska
No Placebo Group
Approved in 2 Jurisdictions
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.
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.
12345What 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.
56789Is the treatment Novel DBS stimulation patterns a promising treatment for Parkinson's Disease?
Yes, Novel DBS stimulation patterns are promising for Parkinson's Disease. They can improve symptom relief and energy efficiency compared to standard DBS, offering a new way to help manage the disease.
310111213Eligibility 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
I have been on medication and clinical stimulation for 3 months after my DBS system surgery.
You have had surgery to implant devices in both sides of your brain and a specific type of neural stimulator.
You have a strong beta peak measured during surgery.
+3 more
Exclusion Criteria
You need frequent changes to your treatment plan or device settings.
I experience severe side effects from my treatment.
I am not willing to participate in the study.
+4 more
Participant Groups
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.
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.
Novel DBS stimulation patterns is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Percept PC DBS for:
- Parkinson's disease
- Essential tremor
- Epilepsy
- Dystonia
- Obsessive-compulsive disorder
🇪🇺 Approved in European Union as Percept PC DBS for:
- Parkinson's disease
- Essential tremor
- Epilepsy
- Dystonia
- Obsessive-compulsive disorder
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
UNMC/Nebraska MedicineOmaha, NE
Unversity of Nebraska Medical CenterOmaha, NE
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Who Is Running the Clinical Trial?
University of NebraskaLead Sponsor
References
Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. [2017]Deep brain stimulation (DBS) is the treatment of choice for advanced Parkinson's disease. The target co-ordinates are traditionally calculated in relation to the intercommissural distance. Anterior (AC) and posterior commissures (PC) may be visualised by the means of ventriculography, CT or MRI.
Functional Outcome of Bilateral Subthalamic Nucleus-Deep Brain Stimulation in Advanced Parkinson's Disease Patients: A Prospective Study. [2022]Deep brain stimulation (DBS) is an accepted modality of treatment in patients with Parkinson's disease (PD). Although DBS was approved in advanced PD, it is being done in early PD as well. It was mainly developed to help the patients of PD to overcome the adverse motor effects associated with treatment and treatment failure.
Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review. [2022]Deep brain stimulation (DBS) for Parkinson's disease (PD) has been applied to clinic for approximately 30 years. The goal of this review is to explore the similarities and differences between "awake" and "asleep" DBS techniques.
Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. [2020]Deep brain stimulation (DBS) markedly improves motor function in advanced Parkinson's disease (PD), but its effect on sleep is less clear.
Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]The Medtronic "Percept" is the first FDA-approved deep brain stimulation (DBS) device with sensing capabilities during active stimulation. Its real-world signal-recording properties have yet to be fully described.
Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. [2021]Label="INTRODUCTION" NlmCategory="BACKGROUND">Several software and hardware advances in the field of deep brain stimulation (DBS) have been realized in recent years and devices from three manufacturers are available. The Percept™ PC platform (Medtronic, Inc.) enables brain sensing, the latest innovation. Clinicians should be familiar with the differences in devices, and with the latest technologies to deliver optimized patient care.Areas covered: In this device profile, the sensing capabilities of the Percept™ PC platform are described, and the system capabilities are differentiated from other available platforms. The development of the preceding Activa™ PC+S research platform, an investigational device to simultaneously sense brain signals and provide therapeutic stimulation, is provided to place Percept™ PC in the appropriate context.Expert opinion: Percept™ PC offers unique sensing and diary functions as a means to refine therapeutic stimulation, track symptoms and correlate them to neurophysiologic characteristics. Additional features enhance the patient experience with DBS, including 3 T magnetic resonance imaging compatibility, wireless telemetry, a smaller and thinner battery profile, and increased battery longevity. Future work will be needed to illustrate the clinical utility and added value of using sensing to optimize DBS therapy. Patients implanted with Percept™ PC will have ready access to future technology developments.
Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study. [2022]Deep brain stimulation (DBS) is a common surgical option for the treatment of medically refractory Parkinson's disease (PD). Manufacturer and User Facility Device Experience (MAUDE), a United States Food and Drug Administration (FDA)-compiled database of adverse event reports related to medical devices, is a public resource that can provide insight into the relative frequency of complications and patient complaints.
Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. [2021]We describe the case of a 51-year-old man with Parkinson's disease (PD) presenting with motor fluctuations, who received bilateral subthalamic deep brain stimulation (DBS) with an adaptive DBS (aDBS) device, Percept™ PC (Medtronic, Inc. , Minneapolis, MN). This device can deliver electrical stimulations based on fluctuations of neural oscillations of the local field potential (LFP) at the target structure. We observed that the LFP fluctuations were less evident inside the hospital than outside, while the stimulation successfully adapted to beta oscillation fluctuations during the aDBS phase without any stimulation-induced side effects. Thus, this new device facilitates condition-dependent stimulation; this new stimulation method is feasible and provides new insights into the pathophysiological mechanisms of PD.
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]Introduction Deep brain stimulation (DBS) is a modality of treatment for medication refractory Parkinson's disease (PD) in patients with debilitating motor symptoms. While potentially life-changing for individuals with Parkinson's disease, characterization of adverse events for these DBS devices have not yet been systematically organized. Therefore, the goal of this study was to characterize reported complications of DBS devices reported to the Food & Drug Administration over the last 10 years. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was utilized to retrieve entries reported under "Stimulator, Electrical, Implanted, For Parkinsonian Symptoms" between July 31, 2010 and August 1, 2020. After removing duplicate entries, each unique adverse event reported was sorted into complication categories based on the entries' provided narrative description. A final tabulation of complications was generated. Results The search query revealed 221 unique adverse events. The most common DBS devices were the Vercise Gevia, Vercise Cartesia and Vercise PC produced by Boston Scientific (Brian Walker, Boston Scientific, Marlborough, MA, USA). The most commonly reported complications were infection (16.2%) follow by lead migrations (8.6%). Other common causes of complications were circuit-related impedance (6.5%), cerebral bleeds (6.3%), device failure (6.3%) and device-related trauma (4.5%). Over a third (40%) of all devices reported with adverse events required returning to the operating room for explant or revision. Conclusion The most common complications of DBS systems are infections followed by lead migrations. Further research is needed to minimize infection rates associated with DBS systems and to reduce intrinsic device malfunctions for patients in the future.
[Deep brain stimulation in Parkinson's disease. Preliminary outcomes]. [2018]Parkinson's disease justifies the use of deep brain stimulation (DBS) in certain patients who suffer from this condition. We present mid-term and long-term post-surgical outcomes in a cohort of 60 patients, who underwent DBS in the Hospital de Especialidades at Centro Médico Nacional Siglo XXI, in Mexico City.
Is awake physiological confirmation necessary for DBS treatment of Parkinson's disease today? A comparison of intraoperative imaging, physiology, and physiology imaging-guided DBS in the past decade. [2019]Deep brain stimulation (DBS) is a well-established surgical therapy for Parkinson's disease (PD). Intraoperative imaging (IMG), intraoperative physiology (PHY) and their combination (COMB) are the three mainstream DBS guidance methods.
Temporally optimized patterned stimulation (TOPS®) as a therapy to personalize deep brain stimulation treatment of Parkinson's disease. [2022]Deep brain stimulation (DBS) is a well-established therapy for the motor symptoms of Parkinson's disease (PD), but there remains an opportunity to improve symptom relief. The temporal pattern of stimulation is a new parameter to consider in DBS therapy, and we compared the effectiveness of Temporally Optimized Patterned Stimulation (TOPS) to standard DBS at reducing the motor symptoms of PD. Twenty-six subjects with DBS for PD received three different patterns of stimulation (two TOPS and standard) while on medication and using stimulation parameters optimized for standard DBS. Side effects and motor symptoms were assessed after 30 min of stimulation with each pattern. Subjects experienced similar types of side effects with TOPS and standard DBS, and TOPS were well-tolerated by a majority of the subjects. On average, the most effective TOPS was as effective as standard DBS at reducing the motor symptoms of PD. In some subjects a TOPS pattern was the most effective pattern. Finally, the TOPS pattern with low average frequency was found to be as effective or more effective in about half the subjects while substantially reducing estimated stimulation energy use. TOPS DBS may provide a new programing option to improve DBS therapy for PD by improving symptom reduction and/or increasing energy efficiency. Optimizing stimulation parameters specifically for TOPS DBS may demonstrate further clinical benefit of TOPS DBS in treating the motor symptoms of Parkinson's disease.
Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]Deep brain stimulation (DBS) is an established procedure for the symptomatic treatment of Parkinson's disease. Several deep brain nuclei have been stimulated, producing a wide range of effects on the motor and non-motor symptoms of Parkinson's disease. Long-term, high-quality evidence is available for stimulation of the subthalamic nucleus and globus pallidus internus, both of which uniformly improve motor features, and for stimulation of the thalamic ventralis intermedius, which improves tremor. Short-term data are available for stimulation of other deep brain targets, such as the pedunculopontine nucleus and the centremedian/parafascicular thalamic complex. Some non-motor symptoms improve after DBS, partly because of motor benefit or reduction of drug treatment, and partly as a direct effect of stimulation. More evidence on the effects of DBS on non-motor symptoms is needed and specifically designed studies are warranted.