An interventional study of Deep Brain Stimulation - Minimal Electrophysiology and Deep Brain Stimulation - Standard in Parkinson Disease, sponsored by Nova Scotia Health Authority. Not yet recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Treatment
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:
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 80 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants undergoing DBS for the diagnosis of Parkinson's disease
Procedure: Deep Brain Stimulation - Minimal Electrophysiology
Participants who previously underwent DBS surgery for the diagnosis of Parkinson's disease
Procedure: Deep Brain Stimulation - Standard
Participants will undergo standard work-up and follow-up for DBS, but with minimal intraoperative electrophysiological testing.
Participants underwent DBS surgery with standard intraoperative electrophysiological testing.
Accuracy of implanted electrode position
The distance between the final implanted electrode and the planned electrode, as measured on imaging software.
Time frame: Intraoperative
Change in disease score units on the Unified Parkinson's Disease Rating Scale
Assessment of therapeutic effects using the Unified Parkinson Disease Rating Scale
Time frame: Baseline, 12 months
Change in disease score units on the Parkinsons Disease Questionnaire
Assessment of therapeutic effects using the Parkinsons Disease Questionnaire
Time frame: Baseline, 12 months
Efficiency of Surgery
Assessment of operating room times and length of stay in hospital
Time frame: Intraoperative
Intraoperative intensity of stimulation in milliampere
Intraoperative intensity of stimulation in milliamp, which elicits an activation of contralateral muscle groups (musculus interosseus dorsalis and the musculus tibialis anterior)
Time frame: Intraoperative
Safety of streamlined protocol
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
Time frame: 4, 16, and 52 weeks post-surgery
Plan to share: Undecided
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This study is not yet recruiting, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Nova Scotia Health Authority