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

NCT05569213 | Unknown FDA Device

• 1 other identifier: HS25589
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

MEP Onset Latency

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

motor evoked potentials DIAGNOSTIC_TEST

see previous descriptions

DBS latency/MEP latency

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Manitoba: lead

MeSH Terms

Interventions

Evoked Potentials, Motor

Intervention Hierarchy (Ancestors)

Evoked Potentials; Cortical Excitability; Electrophysiological Phenomena; Physiological Phenomena; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marshall F Wilkinson, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marshall F Wilkinson, PhD

CONTACT

204 787-4675; mwilkinson@hsc.mb.ca

Philippe Magown, MD

CONTACT

204 787-3524; pmagown@deerlodge.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 6, 2022

Record last verified: 2022-08