NCT05569213

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 10 (estimated)
• Sponsor: University of Manitoba · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: —

Summary

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.

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.

Conditions

• MEP Onset Latency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	motor evoked potentials	see previous descriptions

Timeline

• Start date: 2022-10-01
• Primary completion: 2023-10-01
• Completion: 2023-12-01
• First posted: 2022-10-06
• Last updated: 2022-10-06

Regulatory

• FDA-regulated device study