MEP Onset LatencyDBS MEPNCT05569213
Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP)
An observational study of MEP Onset Latency, run by University of Manitoba.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- MEP Onset Latency
- What is being tested?
- motor evoked potentials
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 35 to 75 years
- All sexes
- Adult, Older adult
Study population: The patient population will be those diagnosed with medically refractory Parkinson's Disease or Essential tremor and scheduled for DBS surgery.
Who may be able to join
- Male or female patients scheduled for DBS surgery under general anesthesia; age 35-75 years; no history of stroke or peripheral nerve disease
Who cannot join
- peripheral nerve disease (e.g. type I diabetes); demyelinating disease (e.g. multiple sclerosis); previous stroke; allergy to propofol based anesthesia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Being tested
- motor evoked potentials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor evoked potentialsDiagnostic test
see previous descriptions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: motor evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MEP Onset LatencyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marshall F Wilkinson, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569213
- Sponsor's protocol ID
- HS25589
- Acronym
- DBS MEP
- Status last verified
- Aug 2022
- First submitted
- 3 Oct 2022
- Last updated
- 6 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: onset latencies derived from conventional and DBS-induced MEP will be available upon study completion
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Deep Brain Stimulation (DBS) and Motor Evoked Potentials (MEP) to Map Activation Loci in the Human Corticospinal Tract
- ClinicalTrials.gov ID
- NCT05569213
- Acronym / sponsor ID
- DBS MEP / HS25589
- Conditions
- MEP Onset Latency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS latency/MEP latency | – | Diagnostic Test: motor evoked potentialsEach 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. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The patient population will be those diagnosed with medically refractory Parkinson's Disease or Essential tremor and scheduled for DBS surgery.
Key inclusion criteria (1 listed)
- Male or female patients scheduled for DBS surgery under general anesthesia; age 35-75 years; no history of stroke or peripheral nerve disease
Key exclusion criteria (1 listed)
- peripheral nerve disease (e.g. type I diabetes); demyelinating disease (e.g. multiple sclerosis); previous stroke; allergy to propofol based anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| motor evoked potentialssee previous descriptions | Diagnostic test | DBS latency/MEP latency |
Primary outcome
Combining deep brain stimulation (DBS) and motor evoked potentials (MEP) to map activation loci in the human corticospinal tract
Time frame: 12 months
onset latency of motor evoked potentials
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2022.
- Individual participant dataSharing planned: Undecided. onset latencies derived from conventional and DBS-induced MEP will be available upon study completion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marshall F Wilkinson, PhD principal investigator
University of Manitoba
Questions about this trial
What is this clinical trial studying?
An observational study of MEP Onset Latency, run by University of Manitoba.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marshall F Wilkinson, PhD (204 787-4675, mwilkinson@hsc.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combining deep brain stimulation (DBS) and motor evoked potentials (MEP) to map activation loci in the human corticospinal tract (time frame: 12 months). 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 6 Oct 2022.