Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP) (DBS MEP)

Combining Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP) to Map Activation Loci in the Human Corticospinal Tract

MEP onset latencies from the hand muscle using two different stimulus methods will be compared from each study participant. Conventional MEP data will be collected prior to skin incision. Following the DBS insertion hand muscle evoked responses will be generated via the DBS electrode. A hand held DBS programmer will be connected to the proximal end of the implanted DBS for delivery of electrical stimuli. Stimulus intensity will be adjusted until a hand muscle evoked potential is registered from the same recording electrodes used for the conventional MEP acquisition. A STN-implanted electrode can produce hand muscle responses due to it's close proximity to the motor fibres of the internal capsule. When the conventional and DBS-induced hand muscle responses have been acquired the study data objectives have been met. Data will be analyzed off-line.

Study Overview

• Status: Not yet recruiting
• Conditions: MEP Onset Latency
• Intervention / Treatment: Diagnostic test: motor evoked potentials

Detailed Description

Purpose: Hand muscle MEP generated via the DBS electrode will provide an onset latency standard from which we can compare conventional MEP from the same hand muscles. It is critical for validation of conventional MEP to know where in the brain the motor pathway is being stimulated. This will avoid false negative MEP test results.

Objectives: We will measure the onset latencies from hand muscle MEP generated via the DBS electrode as well as using conventional MEP methods. The DBS onset latency data will provide a known anatomical standard to compare with conventional hand MEP.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Marshall F Wilkinson, PhD; Phone Number: 204 787-4675; Email: mwilkinson@hsc.mb.ca
• Study Contact Backup: Name: Philippe Magown, MD; Phone Number: 204 787-3524; Email: pmagown@deerlodge.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patient population will be those diagnosed with medically refractory Parkinson's Disease or Essential tremor and scheduled for DBS surgery.

Description

Inclusion Criteria:

• Male or female patients scheduled for DBS surgery under general anesthesia; age 35-75 years; no history of stroke or peripheral nerve disease

Exclusion Criteria:

• peripheral nerve disease (e.g. type I diabetes); demyelinating disease (e.g. multiple sclerosis); previous stroke; allergy to propofol based anesthesia

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DBS latency/MEP latency; Each patient will serve as control and test. Control will be latency of hand MEP generated by DBS stimulation of the corticospinal tract. The test condition will be the latency of hand MEP generated by conventional MEP acquisition.	Diagnostic test: motor evoked potentials; see previous descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Combining deep brain stimulation (DBS) and motor evoked potentials (MEP) to map activation loci in the human corticospinal tract	onset latency of motor evoked potentials	12 months

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Marshall F Wilkinson, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: HS25589

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: onset latencies derived from conventional and DBS-induced MEP will be available upon study completion

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes