DBS Stimulation Patterns for Parkinson's Disease

Recruiting at 1 trial location

Overseen By Dulce Maroni, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Must be taking: Anti-Parkinsons

Disqualifiers: Cardiac device, Unstable stimulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 years

10 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 5}

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. ^{5 6 7 8 9}

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. ^{5 6 7 8 9}

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. ^{3 10 11 12 13}

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. ^{2 3 10 11 12}

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

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.

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.

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

Group I: PD with DBS Experimental Treatment 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 40 Parkinson's disease patients undergoing subthalamic deep brain stimulation (STN-DBS), 45% reported significant improvement in sleep quality at 6 months, although this improvement was not statistically significant at 12 months.

The most common benefits included better overall sleep quality and maintenance, but some patients experienced new-onset daytime sleepiness, indicating that while STN-DBS can improve sleep, the effects can vary widely among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. Kharkar, S., Ellenbogen, JR., Samuel, M., et al.[2020]

The Medtronic 'Percept' device, the first FDA-approved deep brain stimulation system with sensing capabilities, was tested on 7 subjects to identify and mitigate artifacts in local field potential signals that could affect its performance.

Using automated template subtraction techniques, researchers successfully removed various artifacts, such as ECG signals and nonphysiologic noise, which could otherwise distort the neural signals and impact the effectiveness of adaptive deep brain stimulation algorithms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. Hammer, LH., Kochanski, RB., Starr, PA., et al.[2023]

The Percept™ PC platform by Medtronic represents a significant advancement in deep brain stimulation (DBS) technology, featuring brain sensing capabilities that allow for real-time monitoring and optimization of therapeutic stimulation.

This device not only enhances patient experience with improved battery life and MRI compatibility but also aims to refine treatment by correlating symptoms with neurophysiological data, although further research is needed to fully establish its clinical benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. Jimenez-Shahed, J.[2021]

A total of 4,189 adverse event reports related to deep brain stimulation for Parkinson's disease were analyzed, revealing that 28% of patient complaints were due to ineffective stimulation, highlighting a significant issue in treatment efficacy.

Among the surgically managed complications, 55% were related to impedance issues, and 28% involved infections, indicating that while DBS can be beneficial, it also carries risks that need to be carefully monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study. Ward, M., Ahmed, M., Markosian, C., et al.[2022]

A 51-year-old man with Parkinson's disease experienced successful motor fluctuation management using an adaptive deep brain stimulation (aDBS) device, which adjusts stimulation based on real-time neural activity.

The aDBS device effectively adapted to changes in beta oscillations without causing side effects, suggesting it is a feasible and innovative approach to enhance treatment for Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. Nakajima, A., Shimo, Y., Fuse, A., et al.[2021]

A review of 221 unique adverse events related to deep brain stimulation (DBS) devices for Parkinson's disease revealed that the most common complications were infections (16.2%) and lead migrations (8.6%).

Over 40% of the reported adverse events required patients to return to the operating room for device explantation or revision, highlighting the need for further research to improve the safety and reliability of DBS systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. Bennett, J., MacGuire, J., Novakovic, E., et al.[2023]

In a study of 60 Parkinson's disease patients who underwent deep brain stimulation (DBS), significant improvements in motor function were observed over 36 months, with UPDRS scores decreasing from 79.57 pre-surgery to 58.75 at 36 months (p < 0.0001).

The procedure had a low complication rate of 15%, with all complications managed conservatively, suggesting that DBS is a safe and effective treatment option for selected patients with Parkinson's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in Parkinson's disease. Preliminary outcomes]. Pérez-de la Torre, RA., Calderón-Vallejo, A., Morales-Briceño, H., et al.[2018]

In a review of 59 studies on deep brain stimulation (DBS) for Parkinson's disease, intraoperative imaging (IMG-DBS) and combined methods (COMB-DBS) showed significantly smaller target errors compared to purely physiological methods (PHY-DBS), indicating better surgical accuracy.

IMG-DBS not only resulted in shorter surgical times but also had a lower risk of intracerebral hemorrhage compared to PHY-DBS and COMB-DBS, suggesting it may be the safer and more efficient option for guiding DBS procedures.

NCBI (Pubmed)

pubmed.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. Yin, Z., Luo, Y., Jin, Y., et al.[2019]

Temporally Optimized Patterned Stimulation (TOPS) was found to be as effective as standard deep brain stimulation (DBS) in reducing motor symptoms of Parkinson's disease in a study involving 26 subjects, suggesting it could be a viable alternative for symptom relief.

TOPS stimulation patterns, particularly those with low average frequency, not only matched the effectiveness of standard DBS but also reduced estimated energy use, indicating potential for improved energy efficiency in DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporally optimized patterned stimulation (TOPS®) as a therapy to personalize deep brain stimulation treatment of Parkinson's disease. Okun, MS., Hickey, PT., Machado, AG., et al.[2022]

Deep brain stimulation (DBS) is effective for treating motor symptoms of Parkinson's disease, particularly when targeting the subthalamic nucleus and globus pallidus internus, which consistently improve motor features.

While some non-motor symptoms also show improvement with DBS, further research is needed to understand these effects better and to explore other deep brain targets like the pedunculopontine nucleus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. Fasano, A., Daniele, A., Albanese, A.[2022]

References

1. Italy pubmed.ncbi.nlm.nih.gov

Multiple sequential image-fusion and direct MRI localisation of the subthalamic nucleus for deep brain stimulation. [2017]

2. India pubmed.ncbi.nlm.nih.gov

Functional Outcome of Bilateral Subthalamic Nucleus-Deep Brain Stimulation in Advanced Parkinson's Disease Patients: A Prospective Study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Comparison of Awake and Asleep Deep Brain Stimulation for Parkinson's Disease: A Detailed Analysis Through Literature Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Changes in Parkinson's disease sleep symptoms and daytime somnolence after bilateral subthalamic deep brain stimulation in Parkinson's disease. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Artifact Characterization and a Multipurpose Template-Based Offline Removal Solution for a Sensing-Enabled Deep Brain Stimulation Device. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Device profile of the percept PC deep brain stimulation system for the treatment of Parkinson's disease and related disorders. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Complications associated with deep brain stimulation for Parkinson's disease: a MAUDE study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Case Report: Chronic Adaptive Deep Brain Stimulation Personalizing Therapy Based on Parkinsonian State. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]

10. Mexico pubmed.ncbi.nlm.nih.gov

[Deep brain stimulation in Parkinson's disease. Preliminary outcomes]. [2018]

11. United States pubmed.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]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Temporally optimized patterned stimulation (TOPS®) as a therapy to personalize deep brain stimulation treatment of Parkinson's disease. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]