10 Participants Needed

DBS Stimulation Patterns for Parkinson's Disease

Recruiting at 1 trial location
JN
DM
Overseen ByDulce Maroni, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Nebraska
Must be taking: Anti-Parkinsons
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications such as infections, lead migrations (movement of the wires), and device malfunctions. About 40% of devices with reported issues required additional surgery to fix or remove them.56789

Is 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.310111213

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

AA

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

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.
See 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.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive novel DBS stimulation patterns and are assessed for motor symptoms and side effects

2 years
Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Novel DBS stimulation patterns
Trial Overview 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.
Participant Groups
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

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials
563
Recruited
1,147,000+

Findings from Research

Deep brain stimulation (DBS) for advanced Parkinson's disease, using Multiple Sequences Image Fusion (MuSIF) for accurate targeting, led to a significant reduction of 76% in L-dopa equivalent daily dose after 3 months.
Patients experienced a 50% reduction in dyskinesias and a 45% decrease in motor fluctuations, demonstrating the efficacy of the combined imaging techniques in improving treatment outcomes.
Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation.Rampini, PM., Locatelli, M., Alimehmeti, R., et al.[2017]
Subthalamic nucleus deep brain stimulation (STN-DBS) significantly reduced motor symptoms in Parkinson's disease patients, with a 35% decrease in Unified Parkinson's Disease Rating Scale-III (UPDRS-III) scores after 6 months, indicating its efficacy in managing motor fluctuations.
The procedure was found to be safe, with no significant impact on cognitive function as measured by the Montreal Cognitive Assessment (MOCA), and it improved the quality of life for patients, although factors like older age and longer disease duration could limit these benefits.
Functional Outcome of Bilateral Subthalamic Nucleus-Deep Brain Stimulation in Advanced Parkinson's Disease Patients: A Prospective Study.Tandra, S., Ramavath, B., Kandadai, RM., et al.[2022]
Both 'awake' and 'asleep' deep brain stimulation (DBS) techniques for Parkinson's disease have reliable targeting accuracy for lead placement, ensuring effective treatment.
There are no significant differences in clinical outcomes, costs, or complications between the two DBS techniques, making them equally viable options for patients.
Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review.Wang, J., Ponce, FA., Tao, J., et al.[2022]

References

Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. [2017]
Functional Outcome of Bilateral Subthalamic Nucleus-Deep Brain Stimulation in Advanced Parkinson's Disease Patients: A Prospective Study. [2022]
Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review. [2022]
Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. [2020]
Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]
Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. [2021]
Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study. [2022]
Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. [2021]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
[Deep brain stimulation in Parkinson's disease. Preliminary outcomes]. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
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]
Temporally optimized patterned stimulation (TOPS®) as a therapy to personalize deep brain stimulation treatment of Parkinson's disease. [2022]
Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]
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