Intervertebral Disc DegenerationNCT05098431
Comparison of Three Approaches of Electrode Placement to Detect Changes in Motor Evoked Potentials During Spine Surgery
A study testing Quadriceps and Rectus Femoris MEP Recording in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Allina Health System at 1 site in United States.
Trial summary
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis
- What is being tested?
- Quadriceps and Rectus Femoris MEP Recording
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Jan 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be ≥18 years of age
- Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
- Patients should have normal preoperative quadriceps strength
- Patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed
Who cannot join
- Patients with ongoing psychiatric concerns would be excluded.
- Patients who are non-English speakers.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55447
About this study
Official title: Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).
Read the detailed description
The long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in Motor Evoked Potentials (MEPs) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.The specific aims of the proposed research are:
- Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
- Evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques.
The initial focus will be on recording techniques to obtain stable MEPs in a proximal lower limb muscle, specifically the quadriceps. Continuation research may focus on stimulation techniques to facilitate proximal MEPs and ultimately to improved specificity of MEP changes.
- Conditions
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spinal Curvatures, Spondylitis, Spondylosis
- Being tested
- Quadriceps and Rectus Femoris MEP Recording
- Keywords
- Intraoperative Neuromonitoring, Motor Evoked Potential
- Medical subject headings
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spinal Curvatures, Spondylitis, Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps and Rectus Femoris MEP RecordingOther
Participants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Receive Quadriceps MEPs during procedure Receives: Other: Quadriceps and Rectus Femoris MEP Recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
MEPs will be evoked throughout the duration of the surgery. MEPs will be recorded in the Rectus Femoris using intramuscular bipolar electrodes.
Measured: Duration of surgery
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Measured: Duration of surgery
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Measured: Duration of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start1 Jul 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Why it stopped: Unable to enroll patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral Disc DegenerationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allina Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey A Strommen, MD, Principal investigator, Allina Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098431
- Sponsor's protocol ID
- 1565509
- Status last verified
- Jul 2024
- First submitted
- 9 Sep 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Approaches of Motor Evoked Potential Recording to Detect a More Reliable Measure to Predict and Prevent Nerve Damage During Spine Surgery
- ClinicalTrials.gov ID
- NCT05098431
- Acronym / sponsor ID
- 1565509
- Conditions
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Stenosis, Spinal Curvatures, Spondylitis, Spondylosis
- Keywords
- Intraoperative Neuromonitoring, Motor Evoked Potential
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allina Health SystemUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 28 Oct 2021 (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.
Motor Evoked Potentials are an aspect of intraoperative neuromonitoring, a tool used by neurophysiologists during surgery to prevent irreversible damage to the spinal cord during procedures. This study investigates the utility of three separate quadriceps MEP recording approaches over a total of 40 limbs (20 participants).
Detailed description
The long-term objective of this research is to understand how differing recording techniques may enhance the ability to accurately identify clinically relevant changes in Motor Evoked Potentials (MEPs) during a variety of surgeries where the central motor tracts or lumbar spinal roots are at risk.The specific aims of the proposed research are:
- Using transcranial magnetic stimulation, evaluate the effects on compound muscle action potentials utilizing intramuscular bipolar recording vs subdermal referential recordings vs subdermal bipolar recordings.
- Evaluated the variability of amplitude and area between the intramuscular and subdermal recording techniques.
The initial focus will be on recording techniques to obtain stable MEPs in a proximal lower limb muscle, specifically the quadriceps. Continuation research may focus on stimulation techniques to facilitate proximal MEPs and ultimately to improved specificity of MEP changes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Other: Quadriceps and Rectus Femoris MEP RecordingReceive Quadriceps MEPs during procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients must be ≥18 years of age
- Patients must be undergoing thoracic or lumbar spine surgery where quadriceps MEP recording would be the standard of care
- Patients should have normal preoperative quadriceps strength
- Patients are capable of understanding the informed consent and have signed the informed consent document prior to any study-specific screening procedures or evaluations being performed
Key exclusion criteria (2 listed)
- Patients with ongoing psychiatric concerns would be excluded.
- Patients who are non-English speakers.
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 |
|---|---|---|
| Quadriceps and Rectus Femoris MEP RecordingParticipants will receive additional electrodes placed intramuscularly to facilitate three separate approaches of quadriceps MEP recording | Other | Experimental Arm |
Primary outcome
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris
Time frame: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. MEPs will be recorded in the Rectus Femoris using intramuscular bipolar electrodes.
Motor Evoked Potentials recorded with a subcutaneous referential electrodes in the Rectus Femoris
Time frame: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Motor Evoked Potentials recorded with secondary subcutaneous referential electrodes in the Rectus Femoris
Time frame: Duration of surgery
MEPs will be evoked throughout the duration of the surgery. Electrodes will be placed in the Rectus Femoris to serve as a reference.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Jeffrey A Strommen, MD principal investigator
Allina Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps and Rectus Femoris MEP Recording in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Allina Health System at 1 site in United States.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Evoked Potentials recorded with an Intramuscular bipolar electrodes in the Rectus Femoris (time frame: Duration of surgery). The study lists 3 primary outcomes in all. 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 12 Jul 2024.