Parkinson DiseaseMIXT-DBSNCT06572150
Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation
A study testing Deep Brain Stimulation - Minimal Electrophysiology and Deep Brain Stimulation - Standard in people with Parkinson Disease, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Deep Brain Stimulation - Minimal Electrophysiology and Deep Brain Stimulation - Standard
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient qualifying for deep brain stimulation for the diagnosis of Parkinson's disease
- Informed consent
Who cannot join
- Lack of consent
- Electrical or other devices that preclude the performance of magnetic resonance imaging
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Queen Elizabeth Health Science Centre
Halifax, Nova Scotia, B3H 3A7
About this study
Official title: Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation (MIXT-DBS)
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?
Read more
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.
Read the 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
- Being tested
- Deep Brain Stimulation - Minimal Electrophysiology, Deep Brain Stimulation - Standard
- Keywords
- Deep Brain Stimulation, Motor evoked potentials
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain Stimulation - Minimal ElectrophysiologyProcedure or surgery
Participants will undergo standard work-up and follow-up for DBS, but with minimal intraoperative electrophysiological testing.
Deep Brain Stimulation - StandardProcedure or surgery
Participants underwent DBS surgery with standard intraoperative electrophysiological testing.
| Study group | Role | What they receive |
|---|---|---|
| Minimal Intraoperative Electrophysiology | Experimental | Participants undergoing DBS for the diagnosis of Parkinson's disease Receives: Procedure: Deep Brain Stimulation - Minimal Electrophysiology |
| Standard Intraoperative Electrophysiology | Other | Participants who previously underwent DBS surgery for the diagnosis of Parkinson's disease Receives: Procedure: Deep Brain Stimulation - Standard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of implanted electrode position
The distance between the final implanted electrode and the planned electrode, as measured on imaging software.
Measured: Intraoperative
Secondary outcomes (5)
Change in disease score units on the Unified Parkinson's Disease Rating Scale
Assessment of therapeutic effects using the Unified Parkinson Disease Rating Scale
Measured: Baseline, 12 months
Change in disease score units on the Parkinsons Disease Questionnaire
Assessment of therapeutic effects using the Parkinsons Disease Questionnaire
Measured: Baseline, 12 months
Efficiency of Surgery
Assessment of operating room times and length of stay in hospital
Measured: 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)
Measured: 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
Measured: 4, 16, and 52 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study startOct 2025 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lutz Weise, MD, PhD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572150
- Sponsor's protocol ID
- MIXT-DBS
- Acronym
- MIXT-DBS
- Status last verified
- Feb 2025
- First submitted
- 23 Aug 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation (MIXT-DBS)
- ClinicalTrials.gov ID
- NCT06572150
- Acronym / sponsor ID
- MIXT-DBS / MIXT-DBS
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Motor evoked potentials
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal Intraoperative Electrophysiology | Experimental | Procedure: Deep Brain Stimulation - Minimal ElectrophysiologyParticipants undergoing DBS for the diagnosis of Parkinson's disease |
| Standard Intraoperative Electrophysiology | Other | Procedure: Deep Brain Stimulation - StandardParticipants who previously underwent DBS surgery for the diagnosis of Parkinson's disease |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient qualifying for deep brain stimulation for the diagnosis of Parkinson's disease
- Informed consent
Key exclusion criteria (2 listed)
- Lack of consent
- Electrical or other devices that preclude the performance of magnetic resonance imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain Stimulation - Minimal ElectrophysiologyParticipants will undergo standard work-up and follow-up for DBS, but with minimal intraoperative electrophysiological testing. | Procedure or surgery | Minimal Intraoperative Electrophysiology |
| Deep Brain Stimulation - StandardParticipants underwent DBS surgery with standard intraoperative electrophysiological testing. | Procedure or surgery | Standard Intraoperative Electrophysiology |
Primary outcome
Accuracy of implanted electrode position
Time frame: Intraoperative
The distance between the final implanted electrode and the planned electrode, as measured on imaging software.
5 secondary outcomes
Change in disease score units on the Unified Parkinson's Disease Rating Scale
Time frame: Baseline, 12 months
Change in disease score units on the Parkinsons Disease Questionnaire
Time frame: Baseline, 12 months
Efficiency of Surgery
Time frame: Intraoperative
Intraoperative intensity of stimulation in milliampere
Time frame: Intraoperative
Safety of streamlined protocol
Time frame: 4, 16, and 52 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lutz Weise, MD, PhD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Brain Stimulation - Minimal Electrophysiology and Deep Brain Stimulation - Standard in people with Parkinson Disease, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lutz Weise, MD, PhD (902-473-6850, lutz.weise@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of implanted electrode position (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.