Deep Brain Stimulation for Parkinson's Disease

Overseen By Kelly Ryberg, MA, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Neurological disorder, Dementia, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

25 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Deep Brain Stimulation for Parkinson's Disease?

Research shows that Deep Brain Stimulation (DBS) is a promising treatment for Parkinson's Disease, especially for patients who no longer respond well to medication. It helps relieve motor symptoms and improve quality of life, making it a well-established option for some patients. ^{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 such as infections (2-16.2%), bleeding in the brain (1-6.3%), and seizures (1-3%). Some patients may also experience neurobehavioral changes, and in rare cases, an intracranial abscess can occur. ^{6 7 8 9 10}

How is the treatment Deep Brain Stimulation (DBS) different from other treatments for Parkinson's Disease?

Deep Brain Stimulation (DBS) is unique because it involves surgically implanting electrodes in the brain to send electrical impulses, which helps control motor symptoms in Parkinson's Disease, unlike medications that are taken orally and work by altering brain chemistry. ^{2 3 4 11 12}

What is the purpose of this trial?

When a patient gets DBS surgery, the neurosurgeon makes a hole in the skull through which they can put the DBS lead down in deep parts of the brain that help control movement. For this study, research participants will also have an ECoG strip put through the same hole (no extra holes are being made for research purposes). The ECoG strip is a little less than half an inch wide, and a little more than 2.5 inches long. It is very, very thin; it is a thin plastic film with flat metal sensors that can record the electrical activity in the brain. The ECoG strips are FDA approved. The neurosurgeon will slide the ECoG strip under the skull but on top of the brain, over another area of the brain that helps control hand/arm movement (motor cortex), so that the study team can record the activity there. The study team will record brain activity from the DBS lead and the ECoG strip simultaneously to try to understand how the brain communicates and sends information. The study team will check that the ECoG strip is in the right place by delivering a very small electrical pulse to the wrist. If the ECoG strip is in the correct location, this electrical pulse will show up on the brain activity being recorded by the sensors in the ECoG strip. Fluoroscopy (i.e. X-ray images that can be taken quickly) will also be done at the end of the surgery to help confirm the location of the ECoG strip. During fluoroscopy, an X-ray beam is used to track a contrast agent ("X-ray dye") through the body, so that the body can be seen in detail. This involves some radiation exposure for the participant, so this is described in the consent form. Patients who want to sign up for the study will not be allowed to do so if they have had other radiation exposures within the past year that would go over a safe limit when added to the amount of radiation expected from the fluoroscopy for this study.

Research Team

Joshua E Aman

Principal Investigator

University of Minnesota

Eligibility Criteria

This trial is for individuals with Parkinson's Disease who may also have an overactive bladder. Participants must be candidates for DBS surgery, a procedure to control movement issues. They should not have had significant radiation exposure in the past year that would combine unsafely with this study's requirements.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

I am between 21 and 75 years old.

I am scheduled for DBS surgery at UMN as part of my treatment plan.

Exclusion Criteria

I do not have any major neurological conditions besides Parkinson's.

Known research radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy

History of dementia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Recording

Participants undergo DBS surgery with ECoG strip placement and initial brain activity recording

1 day

1 visit (in-person)

Post-Surgery Stimulation and Mapping

Participants perform motor and cognitive tasks while brain activity is recorded and stimulation is applied

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery and stimulation

4 weeks

Treatment Details

Interventions

• Deep Brain Stimulation (DBS)

Trial Overview The trial studies how brain regions involved in movement communicate during DBS surgery. An ECoG strip records brain activity alongside the DBS lead. The correct placement of the ECoG strip is confirmed by electrical pulse tests and fluoroscopy (a type of X-ray).

Participant Groups

Group I: Study group Experimental Treatment 1 Intervention

Parkinson's patients with DBS surgery planned as part of routine clinical care

Deep Brain Stimulation (DBS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Deep Brain Stimulation for:

• Advanced Parkinson's disease
• Medically refractory tremor
• Dystonia
• Obsessive-compulsive disorder

Approved in European Union as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia
• Psychiatric conditions

Approved in Canada as Deep Brain Stimulation for:

• Parkinson's disease
• Essential tremor
• Dystonia

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Findings from Research

Deep Brain Stimulation (DBS) significantly alters the experience of living with Parkinson's disease, leading to major bodily changes and a three-phase adjustment process for patients over the first year of treatment.

Patients' experiences with DBS vary widely, with some feeling liberated while others struggle with loss of control and uncertainty, highlighting the need for healthcare professionals to provide support during this adjustment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From miracle to reconciliation: a hermeneutic phenomenological study exploring the experience of living with Parkinson's disease following deep brain stimulation. Haahr, A., Kirkevold, M., Hall, EO., et al.[2010]

Deep Brain Stimulation (DBS) is an established treatment for Parkinson's Disease, and standardized postoperative programming can enhance symptom relief and quality of life for patients.

An expert consensus developed by Chinese specialists aims to standardize DBS programming, which is expected to improve the overall management of patients after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease. Chen, S., Gao, G., Feng, T., et al.[2022]

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]

Deep brain stimulation (DBS) is an effective treatment for Parkinson's disease, but it requires careful adherence to specific guidelines when performing MRI to avoid serious complications.

A case study highlighted a permanent neurological injury caused by improper use of MRI in a patient with a DBS device, emphasizing the critical need for following manufacturer guidelines to ensure patient safety during imaging procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson's disease: case report. Henderson, JM., Tkach, J., Phillips, M., et al.[2019]

In a study of 30 patients with early-stage Parkinson's disease, those receiving deep brain stimulation (DBS) alongside optimal drug therapy showed some initial cognitive declines, particularly in attention and executive function, compared to those on drug therapy alone.

Despite two serious adverse events in the DBS group, cognitive differences were less pronounced at the 24-month follow-up, suggesting that DBS may have a manageable impact on cognitive function over time, especially when considering the overall benefits of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuropsychological effects of deep brain stimulation in subjects with early stage Parkinson's disease in a randomized clinical trial. Tramontana, MG., Molinari, AL., Konrad, PE., et al.[2016]

Deep brain stimulation (DBS) is a safe and effective surgical treatment for advanced Parkinson's disease, with a low incidence of serious complications, as shown in a study of 130 patients over several years.

In this study, 62% of patients experienced no complications, and the most common issues were minor, such as aborted procedures (5.14%) and seizures (4.7%), indicating that DBS has a favorable safety profile compared to other surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. Seijo, FJ., Alvarez-Vega, MA., Gutierrez, JC., et al.[2019]

Deep Brain Stimulation (DBS) for Parkinson's disease can lead to rare complications, such as an intracranial abscess, as demonstrated in a case involving a 59-year-old male who developed significant inflammation and required multiple surgeries after the procedure.

Despite the complications, the patient's Parkinson's symptoms improved after the abscess was surgically drained, suggesting that the abscess may have inadvertently provided some therapeutic benefit similar to a subthalomotomy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. Brandão, E., Rosas, MJ., Abreu, P., et al.[2013]

Deep brain stimulation (DBS) can improve motor function and quality of life in patients with Parkinson's disease when used alongside traditional medication, particularly for those whose symptoms are not well-controlled by medication alone.

However, while DBS offers significant benefits, it also comes with a higher risk of adverse events compared to pharmacotherapy, highlighting the need to carefully consider the risks and benefits before opting for this surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. Sharma, A., Szeto, K., Desilets, AR.[2012]

Deep brain stimulation (DBS) of the subthalamic nucleus (STN) significantly improved motor symptoms in a 44-year-old woman with Parkinson's disease, but also caused uncontrollable laughter, highlighting the potential for neurobehavioral side effects.

The use of directional electrodes allowed for more precise stimulation, which helped to minimize undesirable side effects while optimizing motor improvement, suggesting that careful programming and electrode placement are crucial for effective DBS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. Alonso-Frech, F., Fernandez-Garcia, C., Gómez-Mayordomo, V., et al.[2022]

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]

Out of 1017 patients with Parkinson's disease experiencing motor complications, only 35% (78 patients) expressed willingness to undergo deep brain stimulation (DBS) surgery, and ultimately only 18% (41 patients) were able to proceed with the surgery due to pre-operative fitness assessments.

Patients who opted for DBS tended to be older, have a higher socioeconomic status, and had longer durations of Parkinson's disease and motor complications, indicating that many patients wait until later stages of the disease to consider surgical options, which can lead to being deemed unfit for surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep Brain Stimulation for Parkinson's Disease-the Developing World's Perspective. Patel, K., Kalikavil Puthanveedu, D., Vijayaraghavan, A., et al.[2023]

Deep brain stimulation (DBS) can significantly improve quality of life in carefully selected patients with Parkinson's disease, even in cases where traditional treatments like levodopa are ineffective.

This case report of a 47-year-old woman with severe, levodopa-unresponsive symptoms shows that with a thorough evaluation and an interdisciplinary approach, DBS can be beneficial for patients with advanced Parkinson's disease, challenging the notion that certain symptoms are absolute contraindications for the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic Nucleus Deep Brain Stimulation in a Patient with Severe Axial Symptoms and Suboptimal Levodopa Responsive Parkinson's Disease. Nassehi, B., Assadnejad, T., Yildiz, O., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

From miracle to reconciliation: a hermeneutic phenomenological study exploring the experience of living with Parkinson's disease following deep brain stimulation. [2010]

2. England pubmed.ncbi.nlm.nih.gov

Chinese expert consensus on programming deep brain stimulation for patients with Parkinson's disease. [2022]

3. 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]

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

Permanent neurological deficit related to magnetic resonance imaging in a patient with implanted deep brain stimulation electrodes for Parkinson's disease: case report. [2019]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Neuropsychological effects of deep brain stimulation in subjects with early stage Parkinson's disease in a randomized clinical trial. [2016]

6. Austria pubmed.ncbi.nlm.nih.gov

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

Intracerebral abscess: a rare complication of Deep Brain Stimulation. [2013]

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

Efficacy and safety of deep brain stimulation as an adjunct to pharmacotherapy for the treatment of Parkinson disease. [2012]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Non-motor Adverse Effects Avoided by Directional Stimulation in Parkinson's Disease: A Case Report. [2022]

10. 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]

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

Deep Brain Stimulation for Parkinson's Disease-the Developing World's Perspective. [2023]

12. Turkey pubmed.ncbi.nlm.nih.gov

Subthalamic Nucleus Deep Brain Stimulation in a Patient with Severe Axial Symptoms and Suboptimal Levodopa Responsive Parkinson's Disease. [2022]