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Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation

Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation (MIXT-DBS)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06572150
Acronym
MIXT-DBS
Enrollment
80
Registered
2024-08-26
Start date
2025-10-31
Completion date
2028-10-31
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation, Motor evoked potentials

Brief summary

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.

Detailed description

In deep brain stimulation (DBS), accurate implantation of the stimulation electrode into the surgical target is crucial for a successful clinical outcome. The classic technique for surgical planning uses stereotactic atlases developed from a limited number of post-mortem samples. To better account for individual variability, imaging- and electrophysiology-based techniques have been developed. Electrophysiological techniques may offer intraoperative insight into anatomical positioning. Macrostimulation and microelectrode recording are gold-standards for simulating the therapeutic effects of stimulation during surgery, as well as predicting the threshold of stimulation-induced side effects. However, these techniques result in increased procedural time, reduced accuracy due to brain shift, and increased procedural risk due to the up to five electrode penetrations through brain tissue for testing. Motor evoked potentials (MEPs) deliver stimulation across the test and final implanted electrode to predict distance to the motor tract, and have been previously shown by our group to be an effective predictor of therapeutic threshold and side effects. High-resolution magnetic resonance imaging (MRI) may be used to directly visualize target structures for individual patients, such as the subthalamic nucleus (STN), internal globus pallidus (GPi), and ventral intermediate nucleus of the thalamus (VIM). However, differentiating between the target and surrounding tissue is challenging for some surgical targets, and pre-surgical MRI may give imprecise coordinates of brain structures due to brain shift during surgery. Advances in machine learning have led to the development of software for assisting with detecting surgical targets from MRI images and for merging intraoperative images with the preoperative MRI images to represent the stereotactic space and verify the electrode position within the operating room setting. Currently, our center uses MEPs, microelectrode recordings, and macrostimulation with software and intraoperative imaging plan and conduct DBS surgeries. Macrostimulation and microelectrode recordings may be redundant with the introduction of intraoperative MEP testing. This study aims to assess the safety, accuracy and clinical outcomes of using the streamlined procedure of MEP testing with imaging and assistive software only. This technique will be referred to as the MiXT technique.

Interventions

PROCEDUREDeep Brain Stimulation - Minimal Electrophysiology

Participants will undergo standard work-up and follow-up for DBS, but with minimal intraoperative electrophysiological testing.

PROCEDUREDeep Brain Stimulation - Standard

Participants underwent DBS surgery with standard intraoperative electrophysiological testing.

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patient qualifying for deep brain stimulation for the diagnosis of Parkinson's disease * Informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of implanted electrode positionIntraoperativeThe distance between the final implanted electrode and the planned electrode, as measured on imaging software.

Secondary

MeasureTime frameDescription
Change in disease score units on the Unified Parkinson's Disease Rating ScaleBaseline, 12 monthsAssessment of therapeutic effects using the Unified Parkinson Disease Rating Scale
Change in disease score units on the Parkinsons Disease QuestionnaireBaseline, 12 monthsAssessment of therapeutic effects using the Parkinsons Disease Questionnaire
Efficiency of SurgeryIntraoperativeAssessment of operating room times and length of stay in hospital
Intraoperative intensity of stimulation in milliampereIntraoperativeIntraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
Safety of streamlined protocol4, 16, and 52 weeks post-surgeryNumber of adverse events (neurological deficits, infections, hemorrhages), hardware complications (e.g. electrode dislocation and breakage), psychiatric side effects (e.g. depression, hypomania, obsessive behaviour), and unexpected stimulation induced side effects

Countries

Canada

Contacts

Primary ContactLutz Weise, MD, PhD
lutz.weise@nshealth.ca902-473-6850

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026