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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new ways to use brain stimulation to help people with Parkinson's disease. Specifically, it examines different patterns of stimulation using a device already approved for Parkinson's treatment. The goal is to determine if these new patterns can improve symptoms more effectively and with fewer side effects. This trial is for individuals who already have a Medtronic Percept PC brain implant and have experienced improvements from their current treatment. Participants should have Parkinson's symptoms well-managed by their current therapy. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance treatment options for Parkinson's disease.

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 prior data suggests that these DBS stimulation patterns are safe for Parkinson's Disease patients?

Research shows that deep brain stimulation (DBS) is generally safe for individuals with movement disorders such as Parkinson's disease. Studies have found that new methods of delivering stimulation can be performed safely. Researchers are testing these methods to enhance treatment effectiveness and reduce side effects. The Medtronic Percept PC device, used in this trial, has FDA approval for treating Parkinson's, indicating its safety for humans. Although the new stimulation methods remain under evaluation, the device's established safety offers reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the novel DBS stimulation patterns because they could offer a big leap forward in treating Parkinson's Disease. Unlike traditional DBS, which typically uses continuous electrical pulses to manage symptoms, these new patterns explore different rhythms and frequencies of stimulation to optimize effectiveness and potentially reduce side effects. This approach aims to tailor the stimulation more closely to the brain's natural activity, which could lead to improved symptom control and better quality of life for patients.

What evidence suggests that these novel DBS stimulation patterns could be effective for Parkinson's disease?

Research shows that deep brain stimulation (DBS) can effectively manage movement symptoms in Parkinson's disease. Earlier studies revealed that patients using new DBS patterns experienced a 50% reduction in involuntary movements and a 45% decrease in movement fluctuations. In this trial, participants will use the Medtronic Percept PC device, approved by the FDA, which includes BrainSense technology. This device customizes treatment by recording brain signals. This advanced method aims to enhance DBS therapy's effectiveness and reduce side effects, improving quality of life by addressing troublesome movement issues and hard-to-treat tremors. ^{1 4 5 6 7}

Who Is on the Research Team?

Aviva Abosch, MD, PhD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/dbs-stimulation-patterns-for-parkinsons-disease-04423

DBS Stimulation Patterns for Parkinson's Disease Patients experienced a 50% reduction in dyskinesias and a 45% decrease in motor fluctuations, demonstrating the efficacy of the combined imaging techniques in ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK591048/

Adaptive Deep Brain Stimulation for the Treatment of ... - NCBI Deep brain stimulation (DBS) is an invasive neurosurgical therapy for patients with movement disorders such as Parkinson disease, essential tremor, and dystonia ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04799470/novel-dbs-stimulation-patterns-for-treatment-of-parkinsons-disease?page=4&id=117&slug=Parkinson's%20disease

Novel DBS Stimulation Patterns for Treatment of ... This is an open-label, non-randomized, proof-of-concept comparison of clinical vs. research stimulation patterns in patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086899/

AI-DBS study: protocol for a longitudinal prospective ... The objective of the AI-DBS study is to identify patient-specific patterns of neuronal activity that are associated with the severity of motor symptoms of PD.

5. tandfonline.com tandfonline.com/doi/full/10.1080/17434440.2021.1909471

Device profile of the percept PC deep brain stimulation ... DBS can control bothersome motor complications and refractory tremor, and has proven efficacy in improving quality of life [Citation5,Citation6]. Essential ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1094715924010171

P067 ACUTE FEASIBILITY OF NOVEL STIMULATION ... Our findings fill critical evidence gaps in the feasibility and safety of delivering novel patterned stimulation. To date, results confirm that novel ...

7. news.medtronic.com news.medtronic.com/Medtronic-pioneering-ADAPT-PD-clinical-trial-methods-manuscript-published,-setting-new-standards-in-Parkinsons-disease-research

Medtronic pioneering ADAPT-PD clinical trial methods ... The preliminary data from the screening and enrollment phase indicate a high brain signal presence both on and off medications, in both DBS ...