Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation

NCT ID: NCT06572150

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2028-10-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Minimal Intraoperative Electrophysiology

Participants undergoing DBS for the diagnosis of Parkinson's disease

Group Type: EXPERIMENTAL

Deep Brain Stimulation - Minimal Electrophysiology

Intervention Type: PROCEDURE

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

Standard Intraoperative Electrophysiology

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

Group Type: OTHER

Deep Brain Stimulation - Standard

Intervention Type: PROCEDURE

Participants underwent DBS surgery with standard intraoperative electrophysiological testing.

Interventions

Deep Brain Stimulation - Minimal Electrophysiology

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

Intervention Type: PROCEDURE

Deep Brain Stimulation - Standard

Participants underwent DBS surgery with standard intraoperative electrophysiological testing.

Intervention Type: PROCEDURE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lutz Weise, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nova Scotia Health Authority

Locations

Queen Elizabeth Health Science Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Central Contacts

Lutz Weise, MD, PhD

Role: CONTACT

lutz.weise@nshealth.ca

902-473-6850

Other Identifiers

MIXT-DBS

Identifier Type: -

Identifier Source: org_study_id