80 Participants Needed

Simplified Deep Brain Stimulation for Parkinson's Disease

(MIXT-DBS Trial)

LW
Overseen ByLutz Weise, MD, PhD
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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 trial coordinators or your doctor.

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

Deep brain stimulation (DBS) is a well-established treatment for advanced Parkinson's disease, showing effectiveness in reducing symptoms like tremors and motor fluctuations. Studies indicate that DBS can be beneficial even in earlier stages of the disease, and it is considered safer compared to other surgical options like thalamotomy.12345

What safety data exists for Deep Brain Stimulation in humans?

Deep Brain Stimulation (DBS) is generally considered safe, but it can have complications. Common issues include infections (16.2% of cases) and lead migrations (8.6%). Some patients may need additional surgery to fix or remove the device, and overall complication rates can exceed 25%, with permanent neurological issues in 4-6% of cases.16789

How is the treatment Deep Brain Stimulation - Minimal Electrophysiology different from other treatments for Parkinson's disease?

Deep Brain Stimulation - Minimal Electrophysiology is a unique approach that simplifies the traditional deep brain stimulation (DBS) procedure by potentially reducing the complexity of electrophysiological monitoring during surgery. This could make the procedure less invasive and more accessible compared to standard DBS, which typically involves detailed microelectrode recording to ensure precise electrode placement.110111213

What is the purpose of this trial?

The goal of this study is to learn if Deep Brain Stimulation (DBS) surgery can be streamlined for patients being treated for Parkinson's disease. The main questions it aims to answer are:* Can a streamlined DBS surgery protocol with minimal electrophysiology and imaging (MiXT) safely replace the current use of intraoperative electrophysiology?* Are we able to improve the efficiency, lower the invasiveness, and improve the clinical outcomes for patients undergoing DBS surgery?Researchers will compare patients undergoing DBS surgery with this streamlined protocol to patients who previously underwent DBS surgery with the standard protocol to see if the accuracy, clinical outcomes, and efficiency improve.Participants will undergo the standard protocol for DBS work-up and follow-up, but with minimal intraoperative electrophysiological testing.

Research Team

LW

Lutz Weise, MD, PhD

Principal Investigator

Nova Scotia Health Authority

Eligibility Criteria

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

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

Exclusion Criteria

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

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Standard Intraoperative ElectrophysiologyExperimental Treatment1 Intervention
Participants who previously underwent DBS surgery for the diagnosis of Parkinson's disease
Group II: Minimal Intraoperative ElectrophysiologyExperimental Treatment1 Intervention
Participants undergoing DBS for the diagnosis of Parkinson's disease

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Findings from Research

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

References

Complications in subthalamic nucleus stimulation surgery for treatment of Parkinson's disease. Review of 272 procedures. [2019]
Subthalamic nucleus deep brain stimulation in early stage Parkinson's disease. [2021]
Subthalamic nucleus stimulation: improvements in outcome with reprogramming. [2006]
Neuropsychological effects of deep brain stimulation in subjects with early stage Parkinson's disease in a randomized clinical trial. [2016]
[Deep brain stimulation for Parkinson's disease]. [2021]
Characterizing Complications of Deep Brain Stimulation Devices for the Treatment of Parkinsonian Symptoms Without Tremor: A Federal MAUDE Database Analysis. [2023]
Safety considerations for deep brain stimulation: review and analysis. [2007]
Deep brain stimulation for Parkinson's disease: prevalence of adverse events and need for standardized reporting. [2008]
Complications of deep brain stimulation in Parkinson's disease: a single-center experience of 517 consecutive cases. [2023]
Treatment of motor and non-motor features of Parkinson's disease with deep brain stimulation. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Deep Brain Stimulation and Microelectrode Recording for the Treatment of Parkinson's Disease. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Deep brain stimulation for Parkinson's disease: surgical technique and perioperative management. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
The role of deep brain stimulation as a surgical treatment for Parkinson's disease. [2005]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security