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

Trial Summary

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 data supports the effectiveness of the treatment Medtronic's Percept PC DBS device for Parkinson's Disease?

Research shows that deep brain stimulation (DBS) significantly improves motor symptoms, functionality, and quality of life in Parkinson's patients. The Percept PC device offers advanced features like brain sensing, which may enhance the effectiveness of DBS therapy. ^{1 2 3 4 5}

Is deep brain stimulation generally safe for humans?

Deep brain stimulation (DBS) is generally considered safe, but it can have complications like infections, device malfunctions, and psychiatric side effects such as depression or suicidal thoughts. Most complications are related to the device or procedure, and patients should be monitored closely after surgery. ^{6 7 8 9 10}

How does deep brain stimulation differ from other treatments for Parkinson's disease?

Deep brain stimulation (DBS) for Parkinson's disease is unique because it involves implanting electrodes in the brain to improve motor symptoms and decision-making abilities, unlike medications that primarily target chemical imbalances. DBS specifically targets the subthalamic nucleus, which can help with decision-making tasks but may also increase impulsivity, a side effect not typically associated with standard drug treatments. ^{1 11 12 13 14}

What is the purpose of this trial?

The study aims to better understand motivation and value-based decision-making in Parkinson's patients through neurophysiology using Medtronic's Percept DBS device. By combining behavioral tasks with neural recordings, the study seeks to uncover how DBS affects motivation, particularly in relation to effort, reward, and timing.

Research Team

Simon J Little, MBBS, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Betting on DBS: Effects of subthalamic nucleus deep brain stimulation on risk taking and decision making in patients with Parkinson's disease. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Deep brain stimulation in Parkinson's disease: meta-analysis of randomized controlled trials. [2022]

3. 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]

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

Parkinson's Patients' Tolerance for Risk and Willingness to Wait for Potential Benefits of Novel Neurostimulation Devices: A Patient-Centered Threshold Technique Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Selecting candidates for Deep Brain Stimulation in Parkinson's disease: the role of patients' expectations. [2020]

6. 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]

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

Treatment results: Parkinson's disease. [2019]

8. 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]

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

Psychiatric and neuropsychiatric adverse events associated with deep brain stimulation: A meta-analysis of ten years' experience. [2022]

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

Deep brain stimulation in movement disorders. [2007]

11. England pubmed.ncbi.nlm.nih.gov

Mechanisms Underlying Decision-Making as Revealed by Deep-Brain Stimulation in Patients with Parkinson's Disease. [2022]

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

Hold your horses: impulsivity, deep brain stimulation, and medication in parkinsonism. [2022]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Deep brain stimulation of the subthalamic nucleus improves reward-based decision-learning in Parkinson's disease. [2022]

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

Impulsivities and Parkinson's disease: delay aversion is not worsened by Deep Brain Stimulation of the subthalamic nucleus. [2021]