Deep Brain Stimulation and Decision-Making Tasks for Parkinson's Disease

(MPPN Trial)

Overseen By Sarah Wang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Severe cognitive impairments, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 3 years

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how deep brain stimulation (DBS) affects motivation and decision-making in people with Parkinson's disease. Researchers use the Medtronic Percept PC DBS device to observe changes in participants' responses to tasks involving effort, rewards, and timing when the stimulation is turned on or off. Eligible participants must have Parkinson's or dystonia, have had a DBS device implanted for more than a month, and not have severe cognitive issues. As an unphased trial, this study provides a unique opportunity to contribute to understanding DBS effects on motivation and decision-making.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that the Medtronic's Percept PC DBS device is safe for Parkinson's patients?

Research has shown that the Medtronic Percept PC DBS device is generally safe for people with Parkinson's disease. The FDA has approved this device for treating the condition. Studies have found that it is well-tolerated when used correctly, and most patients do not experience serious side effects.

However, some people might experience minor issues, such as skin irritation where the device is placed or temporary dizziness. These side effects are usually easy to manage. The device is also safe in certain MRI settings if specific conditions are followed. Overall, evidence suggests that the Percept PC DBS device is a safe option for people with Parkinson's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Medtronic's Percept PC DBS device for Parkinson's disease because it offers a precision approach to brain stimulation. Unlike traditional treatments like medication or older deep brain stimulation devices, the Percept PC can provide tailored stimulation that adjusts to the patient's specific needs, potentially improving symptoms with fewer side effects. Its ability to record brain signals in real-time means it can adapt to changes in the patient's condition, offering a more personalized and dynamic treatment.

What evidence suggests that Medtronic's Percept DBS device is effective for Parkinson's Disease?

Research has shown that Medtronic's Percept PC device effectively treats symptoms of Parkinson's disease. A study published in the Journal of the American Medical Association (JAMA) Neurology found that this device helps manage symptoms through deep brain stimulation (DBS). It features adaptive technology, allowing it to adjust to the patient's needs in real-time. This trial will compare two approaches: one group will receive standard clinically acceptable stimulation through the Medtronic Percept device, while another group will have the stimulation turned off. This method has been successfully marketed and used in other countries, demonstrating its potential to improve movement and quality of life for people with Parkinson's. Overall, evidence supports that this device can significantly benefit those with Parkinson's. ^{4 5 6 7 8}

Who Is on the Research Team?

Simon J Little, MBBS, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for Parkinson's patients who already have a Medtronic Percept PC DBS device implanted. It's not suitable for those with severe cognitive impairments.

Inclusion Criteria

I have Parkinson's Disease.

Has Medtronic Percept PC DBS device implanted in either GPI or STN

Exclusion Criteria

Severe cognitive impairments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform reward-based decision-making tasks under two DBS conditions: stimulation on and off, with neural activity recorded using the Percept device.

Up to 3 years

Multiple sessions in-clinic and at home

Follow-up

Participants are monitored for safety and effectiveness after treatment, with ongoing data collection and analysis.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic's Percept PC DBS device

Trial Overview The study examines how deep brain stimulation (DBS) affects motivation and decision-making in Parkinson's patients, using tasks with the stimulation turned on and off.

How Is the Trial Designed?

Group I: Stimulation Experimental Treatment 2 Interventions

Patients will be getting standard clinically acceptable stimulation within already safety validated stimulation ranges through their Medtronic Percept device.

Group II: No Stimulation Experimental Treatment 2 Interventions

Patients will have stimulation turned off through their Medtronic Percept device.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

University of Birmingham

Collaborator

Trials

295

Recruited

10,710,000+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Rune Labs

Collaborator

Trials

1

Recruited

20+

Published Research Related to This Trial

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]

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]

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]

Deep brain stimulation (DBS) for Parkinson's disease, particularly targeting the subthalamic nucleus (STN), provides significant motor improvement and allows for reduced medication doses, making it a preferred option for younger patients with motor complications.

While STN DBS has advantages like better motor control and lower current consumption, it requires more intensive postoperative management and carries risks such as infection and hematoma, though the overall benefit-to-risk ratio is considered favorable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment results: Parkinson's disease. Pollak, P., Fraix, V., Krack, P., et al.[2019]

Citations

1. news.medtronic.com news.medtronic.com/Groundbreaking-study-published-in-the-Journal-of-the-American-Medical-Association-JAMA-Neurology-demonstrates-effectiveness-of-Medtronic-BrainSense-TM-Adaptive-deep-brain-stimulation-for-people-with-Parkinsons

Groundbreaking study published in the Journal of ... Groundbreaking study published in the Journal of the American Medical Association (JAMA) Neurology demonstrates effectiveness of Medtronic ...

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

Adaptive Deep Brain Stimulation for the Treatment of ... - NCBI Data on the uptake of Percept PC in Canada were not identified. However, a 2018 assessment reported that the rate of DBS surgery was significantly higher than ...

3. medtronic.com medtronic.com/en-us/l/patients/treatments-therapies/deep-brain-stimulation-parkinsons-disease/about-dbs-therapy/dbs-products/percept-pc.html

Percept PC - DBS for Parkinson's Disease Approximately 7 out of 10 DBS-eligible patients with movements disorders may need an MRI within 10 years of receiving their device.1. Approximately 7 out of 10 ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S478B.pdf

P960009/S478 Summary of Safety and Effectiveness (SSED) The adaptive deep brain stimulation (aDBS) feature has been marketed for Parkinson's. Disease in Japan with Model B35200 Percept PC since May 2020 and with ...

5. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2839117

Long-Term Personalized Adaptive Deep Brain Stimulation ... This nonrandomized clinical trial evaluates the use of adaptive deep brain stimulation in Parkinson disease.

6. europe.medtronic.com europe.medtronic.com/xd-en/healthcare-professionals/therapies-procedures/neurological/deep-brain-stimulation/indications-safety-warnings.html

Deep Brain Stimulation - Indications, Safety, and Warnings Medtronic DBS Therapy is contraindicated (not allowed) for patients who are unable to properly operate the neurostimulator and, for Parkinson's disease and ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf/P960009S219b.pdf

summary of safety and effectiveness data (ssed) The Medtronic DBS System for Epilepsy is a totally implanted device that delivers ... PC Neurostimulation System for. Parkinson's Disease ...

8. medtronic.com medtronic.com/en-us/healthcare-professionals/products/neurological/deep-brain-stimulation/electrical-stimulation-systems/percept-pc-neurostimulator.html

Percept™ PC Neurostimulator The Percept™ PC is a recharge free neurostimulator with sensing, directionality, and advanced programming capabilities for deep brain stimulation (DBS).