Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06572150
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation MIXT-DBS
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIXT-DBS
Brief Summary:
The goal of this study is to learn if Deep Brain Stimulation DBS surgery can be streamlined for patients being treated for Parkinsons 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None