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NCT Number: NCT06572150

Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Deep Brain Stimulation - Minimal Electrophysiology

Procedure

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

Deep Brain Stimulation - Standard

Procedure

Participants underwent DBS surgery with standard intraoperative electrophysiological testing.

Primary outcomes

  1. Accuracy of implanted electrode position

    Time frame: Intraoperative

    The distance between the final implanted electrode and the planned electrode, as measured on imaging software.

Secondary outcomes

  1. Change in disease score units on the Unified Parkinson's Disease Rating Scale

    Time frame: Baseline, 12 months

    Assessment of therapeutic effects using the Unified Parkinson Disease Rating Scale

  2. Change in disease score units on the Parkinsons Disease Questionnaire

    Time frame: Baseline, 12 months

    Assessment of therapeutic effects using the Parkinsons Disease Questionnaire

  3. Efficiency of Surgery

    Time frame: Intraoperative

    Assessment of operating room times and length of stay in hospital

  4. Intraoperative intensity of stimulation in milliampere

    Time frame: Intraoperative

    Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)

  5. Safety of streamlined protocol

    Time frame: 4, 16, and 52 weeks post-surgery

    Number 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

Study contacts

Contact information is provided by the study sponsor or research team.

Lutz Weise, MD, PhD

CONTACT

[email protected]

902-473-6850

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

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

Acronym: MIXT-DBS

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 26, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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