Simplified Deep Brain Stimulation for Parkinson's Disease
(MIXT-DBS Trial)
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery
Participants undergo DBS surgery using the MiXT technique with minimal intraoperative electrophysiological testing
Post-surgery Follow-up
Participants are monitored for safety and effectiveness after surgery, including assessment of adverse events and therapeutic effects
Treatment Details
Interventions
- Deep Brain Stimulation - Minimal Electrophysiology
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor