Clinical trial NCT06572150: Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation
Official title: Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation (MIXT-DBS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Motor evoked potentials
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of implanted electrode position
timeFrame: Intraoperative
Secondary outcomes:
measure: Change in disease score units on the Unified Parkinson's Disease Rating Scale
timeFrame: Baseline, 12 months
measure: Change in disease score units on the Parkinsons Disease Questionnaire
timeFrame: Baseline, 12 months
measure: Efficiency of Surgery
timeFrame: Intraoperative
measure: Intraoperative intensity of stimulation in milliampere
timeFrame: Intraoperative
measure: Safety of streamlined protocol
timeFrame: 4, 16, and 52 weeks post-surgery
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth Health Science Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Lutz Weise, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: