Minimal Electrophysiology and Imaging Enhanced Deep Brain Stimulation

NCT06572150 | Not Yet Recruiting

• 1 other identifier: MIXT-DBS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation; Motor evoked potentials

Outcome Measures

Primary Outcomes (1)

• Accuracy of implanted electrode position

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

  Intraoperative

Secondary Outcomes (5)

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

  Baseline, 12 months

• Change in disease score units on the Parkinsons Disease Questionnaire

  Baseline, 12 months

• Efficiency of Surgery

  Intraoperative

• Intraoperative intensity of stimulation in milliampere

  Intraoperative

• Safety of streamlined protocol

  4, 16, and 52 weeks post-surgery

Study Arms (2)

Minimal Intraoperative Electrophysiology

EXPERIMENTAL

Participants undergoing DBS for the diagnosis of Parkinson's disease

Procedure: Deep Brain Stimulation - Minimal Electrophysiology

Standard Intraoperative Electrophysiology

OTHER

Participants who previously underwent DBS surgery for the diagnosis of Parkinson's disease

Procedure: Deep Brain Stimulation - Standard

Interventions

Deep Brain Stimulation - Minimal Electrophysiology PROCEDURE

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

Minimal Intraoperative Electrophysiology

Deep Brain Stimulation - Standard PROCEDURE

Participants underwent DBS surgery with standard intraoperative electrophysiological testing.

Standard Intraoperative Electrophysiology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient qualifying for deep brain stimulation for the diagnosis of Parkinson's disease
• Informed consent

You may not qualify if:

• Lack of consent
• Electrical or other devices that preclude the performance of magnetic resonance imaging

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth Health Science Centre

Halifax, Nova Scotia, B3H 3A7, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Lutz Weise, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lutz Weise, MD, PhD

CONTACT

902-473-6850; lutz.weise@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

CA (1)