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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

Lutz Weise, MD, PhD contact

902-473-6850

lutz.weise@nshealth.ca

Canada1 site
  • Queen Elizabeth Health Science Centre

    Halifax, Nova Scotia, B3H 3A7

Other trials in Canada

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.

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 groups in NCT06572150
Study groupRoleWhat they receive
Minimal Intraoperative ElectrophysiologyExperimentalParticipants undergoing DBS for the diagnosis of Parkinson's disease
Receives: Procedure: Deep Brain Stimulation - Minimal Electrophysiology
Standard Intraoperative ElectrophysiologyOtherParticipants 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.

  1. 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)
  1. 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

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

    Assessment of therapeutic effects using the Parkinsons Disease Questionnaire

    Measured: Baseline, 12 months

  3. Efficiency of Surgery

    Assessment of operating room times and length of stay in hospital

    Measured: Intraoperative

  4. 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

  5. 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.

  1. First posted26 Aug 2024
  2. Study startOct 2025 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

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)
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

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.

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