Deep Brain Stimulation for Parkinson's Disease

Overseen By Colum MacKinnon, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Musculoskeletal disorders, Neurological disorder, Dementia, 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: Unknown

Duration: 3 weeks

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This protocol will characterize the effects of deep brain stimulation (DBS) location (both adverse and beneficial) on motor signs in people with Parkinson's disease (PD). This information can be used to inform future DBS protocols to tailor stimulation to the specific needs of a patient. If targeted dorsal GP stimulation is shown to significantly improve motor features that are typically resistant to dopamine replacement therapy, these experiments will likely have major impact on clinical practice by providing a potential strategy to these medically intractable symptoms.

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

The protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for more details.

What safety data is available for Deep Brain Stimulation in Parkinson's Disease?

Deep Brain Stimulation (DBS) for Parkinson's Disease has been associated with several complications. Common adverse effects include infections (2-16.2%), hemorrhages (1-6.3%), seizures (1-3%), and lead migrations (8.6%). Other issues include device failures, circuit-related impedance, and device-related trauma. Some complications may require surgical intervention, such as explant or revision. Rare complications like intracerebral abscesses and neurobehavioral events have also been reported. Despite these risks, DBS is generally considered well-tolerated and offers significant benefits over other surgical techniques. ^{1 2 3 4 5}

Is Deep Brain Stimulation a promising treatment for Parkinson's Disease?

Yes, Deep Brain Stimulation (DBS) is a promising treatment for Parkinson's Disease. It is well-established and helps improve the quality of life for patients by reducing symptoms and improving function. DBS is especially beneficial for those with advanced stages of the disease who experience motor complications. ^{6 7 8 9 10}

What data supports the idea that Deep Brain Stimulation for Parkinson's Disease is an effective treatment?

The available research shows that Deep Brain Stimulation (DBS) is an effective treatment for advanced Parkinson's Disease. It helps improve motor symptoms, which are the movement problems caused by the disease. Studies also suggest that DBS might be beneficial even in the early stages of Parkinson's. Compared to just using medication, DBS can provide better control over symptoms when used together with drugs. This means that people with Parkinson's can have a better quality of life with DBS. ^{11 12 13 14 15}

Are You a Good Fit for This Trial?

This trial is for people with Parkinson's disease who have had surgery to implant deep brain stimulators in the globus pallidus or subthalamic nucleus. They must also have existing 7T brain images. It's not open to those with musculoskeletal disorders affecting limb movement, other neurological disorders, dementia, cognitive impairment, or post-operative complications.

Inclusion Criteria

I have been diagnosed with Parkinson's disease.

You have already had a 7T brain scan.

I have had surgery to implant brain stimulators in specific brain areas.

Exclusion Criteria

You have another important neurological condition.

I have a condition that greatly affects my ability to move my arms or legs.

You have a history of memory problems or difficulty thinking clearly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN) and receive targeted stimulation

3 weeks

Follow-up

Participants are monitored for changes in motor signs and adverse effects after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The study is examining how different locations of deep brain stimulation (DBS) within the globus pallidus affect motor symptoms in Parkinson's patients. The goal is to see if targeting specific areas can improve symptoms that don't respond well to medication.

How Is the Trial Designed?

Group I: Parkinson's disease with DBS Experimental Treatment 1 Intervention

Participants will have a diagnosis of idiopathic PD and have undergone/will undergo neurosurgery to implant deep brain stimulators in the globus pallidus (GP DBS) or subthalamic nucleus (STN)

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

Approved in United States as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain
• Stroke-related motor deficits (under investigation)

Approved in European Union as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Approved in Canada as Deep Brain Stimulation for:

• Essential tremor
• Parkinson's disease
• Dystonia
• Obsessive-compulsive disorder
• Epilepsy
• Chronic pain

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

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]

A pilot trial involving 30 subjects with early-stage Parkinson's disease (PD) showed that deep brain stimulation (DBS) combined with optimal drug therapy (ODT) was well tolerated, with most adverse events being mild or transient.

While there were no significant differences in motor function scores between the DBS + ODT group and the ODT-only group at 24 months, the DBS group required lower medication doses, suggesting potential benefits in managing medication needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease. Charles, D., Konrad, PE., Neimat, JS., et al.[2021]

In a study of 44 patients with advanced Parkinson's disease who had been receiving deep brain stimulation (DBS) for an average of 3.5 years, 54.6% showed significant improvements in their symptoms after a neurologist expert reprogrammed their DBS settings and adjusted their medications.

The reprogramming led to a 15.0% improvement in Unified Parkinson's Disease Rating Scale scores for daily living and a 25.9% improvement in motor function, while also allowing for a 25.9% reduction in antiparkinsonian drug dosages, demonstrating the importance of personalized postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subthalamic nucleus stimulation: improvements in outcome with reprogramming. Moro, E., Poon, YY., Lozano, AM., et al.[2006]

In a pilot trial involving 3 patients with advanced Parkinson's disease, combined deep brain stimulation (DBS) of both the subthalamic nucleus (STN) and globus pallidus (GP) led to significant improvements in symptom control, allowing for over 80% reduction in levodopa medication.

The study found that combined DBS resulted in a greater decrease in motor symptoms compared to either STN or GP stimulation alone, and it also reduced beta oscillations in the brain, indicating a potential synergistic effect of the combined approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S. Mitchell, KT., Schmidt, SL., Cooney, JW., et al.[2023]

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]

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]

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) is effective for managing parkinsonian symptoms, but in rare cases, it can lead to severe mood disruptions, as demonstrated by a 58-year-old woman who developed rapid-onset depression during a routine battery replacement procedure after 5 years of DBS treatment.

Electroconvulsive therapy (ECT) proved to be an effective treatment for the patient's severe depression, highlighting its potential as a therapeutic option for patients experiencing intractable mood disorders related to DBS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. Cunningham, MG., Yadollahikhales, G., Vitaliano, G., et al.[2018]

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]

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 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]

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]

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]

Citations

1. 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]

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

Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease. [2021]

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

Subthalamic nucleus stimulation: improvements in outcome with reprogramming. [2006]

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

Initial Clinical Outcome With Bilateral, Dual-Target Deep Brain Stimulation Trial in Parkinson Disease Using Summit RC + S. [2023]

5. 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]

6. 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]

7. Austria pubmed.ncbi.nlm.nih.gov

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

8. Spain pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Administration of electroconvulsive therapy for depression associated with deep brain stimulation in a patient with post-traumatic Parkinson's Disease: a case study. [2018]

10. Switzerland pubmed.ncbi.nlm.nih.gov

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

11. 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]

12. England pubmed.ncbi.nlm.nih.gov

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

13. 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]

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

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

15. 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]