Simplified Deep Brain Stimulation for Parkinson's Disease

(MIXT-DBS Trial)

Overseen By Lutz Weise, MD, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Lack of consent, MRI devices, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new, simpler method for performing Deep Brain Stimulation (DBS) surgery is as safe and effective as the current method for Parkinson's disease. Researchers are streamlining the surgery by using fewer complex tests during the procedure. They seek to discover if this new approach can make the surgery quicker, less invasive, and improve patient outcomes. Individuals with Parkinson's disease who are eligible for DBS surgery might be suitable candidates for this trial. As an unphased trial, this study provides patients the opportunity to contribute to innovative surgical advancements that could enhance treatment outcomes.

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 trial coordinators or your doctor.

What prior data suggests that this streamlined DBS surgery protocol is safe for Parkinson's disease patients?

Studies have shown that Deep Brain Stimulation (DBS) is generally safe for carefully selected patients. The procedure carries low risk, though it might slightly increase hospital visits after surgery. DBS has proven effective in alleviating Parkinson’s disease symptoms such as shaking and stiffness. While complications can occur, they remain uncommon when the procedure is performed with care. These findings suggest that the treatment is well-tolerated and can significantly enhance patients' quality of life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Simplified Deep Brain Stimulation (DBS) technique because it aims to make DBS surgery for Parkinson's disease less complex and more efficient. Traditional DBS involves extensive intraoperative electrophysiology, which can be time-consuming and technically demanding. The new approach minimizes this process, potentially reducing surgery time and simplifying the procedure. This could make DBS more accessible to patients and reduce the burden on surgical teams, without compromising the effectiveness of the treatment.

What evidence suggests that this streamlined DBS protocol is effective for Parkinson's disease?

Research has shown that Deep Brain Stimulation (DBS) can significantly benefit people with Parkinson's disease. Studies have found that DBS reduces movement issues and decreases the need for Parkinson's medication. Specifically, more than half of the recipients experienced better symptom control. In this trial, participants will be assigned to one of two approaches: the standard intraoperative electrophysiology or the newer minimal intraoperative electrophysiology method. The newer DBS method uses simpler testing during surgery, aiming to maintain these benefits while making the procedure easier and less invasive. This could lead to quicker recovery and less time in the operating room for patients. Overall, DBS is a proven treatment that can improve the quality of life for people with Parkinson's. ^{4 5 6 7 8}

Who Is on the Research Team?

Lutz Weise, MD, PhD

Principal Investigator

Nova Scotia Health Authority

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are candidates for Deep Brain Stimulation (DBS) surgery. The study will include those willing to undergo a new, potentially more efficient DBS protocol with minimal electrophysiology and imaging.

Inclusion Criteria

I am eligible for deep brain stimulation due to Parkinson's disease.

Informed consent

Exclusion Criteria

Lack of consent

Electrical or other devices that preclude the performance of magnetic resonance imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo DBS surgery using the MiXT technique with minimal intraoperative electrophysiological testing

Intraoperative

Post-surgery Follow-up

Participants are monitored for safety and effectiveness after surgery, including assessment of adverse events and therapeutic effects

52 weeks

Visits at 4, 16, and 52 weeks post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation - Minimal Electrophysiology

Trial Overview The study tests if a streamlined DBS surgery method can safely replace the current standard involving extensive intraoperative electrophysiology. It compares the new minimal testing approach to traditional methods in terms of accuracy, patient outcomes, and efficiency.

How Is the Trial Designed?

Group I: Standard Intraoperative Electrophysiology Experimental Treatment 1 Intervention

Participants who previously underwent DBS surgery for the diagnosis of Parkinson's disease

Group II: Minimal Intraoperative Electrophysiology Experimental Treatment 1 Intervention

Participants undergoing DBS for the diagnosis of Parkinson's disease

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

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) 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]

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 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 is an effective treatment for movement disorders, involving an implanted electrode and pulse generator, but its mechanisms of action are not fully understood and were developed without extensive preclinical safety studies.

Complication rates for deep brain stimulation can exceed 25%, with 4-6% of patients experiencing permanent neurological issues, highlighting the need for better understanding of adverse events and safer stimulation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for deep brain stimulation: review and analysis. Grill, WM.[2007]

Deep brain stimulation (DBS) for Parkinson's disease is generally safe, with a low mortality rate of 0.2% and permanent morbidity at 0.6%, but complications such as intracerebral hemorrhage (ICH) and seizures can occur in a small percentage of cases.

The study found that the type of lead used in DBS can influence complications, with Medtronic's leads associated with higher rates of perielectrode brain edema compared to Boston Scientific's, highlighting the need for further research on hardware design to improve safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. Servello, D., Galbiati, TF., Iess, G., et al.[2023]

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]

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 an important treatment option for Parkinson's disease, but estimating the prevalence and categorizing adverse events (AEs) associated with it is challenging due to inconsistent reporting.

The authors advocate for a standardized scheme for reporting AEs related to DBS, which would help in conducting meaningful risk/benefit analyses and assist both physicians and patients in making informed decisions about surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. Videnovic, A., Metman, LV.[2008]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3002606/

Deep Brain Stimulation in Parkinson's Disease - PMC STN-DBS results in significant reduction of dyskinesias and dopaminergic medication, improvement of all cardinal motor symptoms with sustained long-term ...

2. nature.com nature.com/articles/s41531-025-01124-7

Chronic adaptive deep brain stimulation for Parkinson's ... On the group level, overall well-being significantly improved with adaptive DBS (p = 0.007), and there was a non-significant trend toward ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S259009352500013X

A comprehensive review of deep brain stimulation for ... In this paper, we explore the history of PD treatments with a focus on DBS, as well as the developments and advancements of the technology.

4. withpower.com withpower.com/trial/simplified-deep-brain-stimulation-for-parkinsons-disease-87874

Simplified Deep Brain Stimulation for Parkinson's Disease · ... 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 ...

5. ufhealth.org ufhealth.org/news/2025/uf-led-study-shows-deep-brain-stimulation-benefits-for-parkinsons-patients

UF-led study shows deep brain stimulation benefits for ... For the first time, we can clearly see that the benefits of DBS, improvements in motor symptoms, reduced medication needs and better quality of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10690827/

Deep brain stimulation in PD: risk of complications ... It is found that, when candidates are carefully screened, DBS is a relatively low-risk procedure, but rate of hospitalization is somewhat increased for DBS ...

7. nature.com nature.com/articles/s41467-024-48731-1

Deep brain stimulation of symptom-specific networks in ... Deep Brain Stimulation can improve tremor, bradykinesia, rigidity, and axial symptoms in patients with Parkinson's disease.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6440024/

An update on best practice of deep brain stimulation in ... Initial data on STN DBS showed an impressive improvement of the Unified Parkinson's Disease Rating Scale motor subscore (UPDRS-III), by 49–71%, and a marked ...