Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05110833
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2021-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055959', 'term': 'Intervertebral Disc Degeneration'}, {'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013130', 'term': 'Spinal Stenosis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D055009', 'term': 'Spondylosis'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001850', 'term': 'Bone Diseases, Infectious'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-19', 'studyFirstSubmitDate': '2021-09-09', 'studyFirstSubmitQcDate': '2021-10-27', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nature of changes in free-run smooth muscle EMG under varying surgical and anesthetic conditions', 'timeFrame': '1 day', 'description': 'Free-run smooth muscle EMG will be monitored continuously throughout the duration of surgery. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.'}, {'measure': 'Nature of changes in free-run smooth muscle EMG resulting from the inadvertent effect of intraoperative monitoring stimulation and recording.', 'timeFrame': '1 day', 'description': 'Smooth muscle EMG in response to stimulations and recordings will be monitored. Any changes in the EMG, as indicated by fluctuation in amplitude and/or frequency, will be recorded.'}, {'measure': 'The believable and repeatable smooth muscle EMG response, if any, measured by amplitude and frequency after deliberate spinal/extra-spinal neural stimulations.', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'Short Form (36) Health Survey', 'timeFrame': '1 year', 'description': 'A self-report survey of patient health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IONM'], 'conditions': ['Intervertebral Disc Degeneration', 'Intervertebral Disc Displacement', 'Spinal Curvatures', 'Spinal Stenosis', 'Spondylitis', 'Spondylosis']}, 'descriptionModule': {'briefSummary': 'Intraoperative Neuromonitoring (IONM) is a tool used by neurophysiologists during spine surgery to prevent irreversible damage to the spinal cord during procedures through a system of alerts. This study investigates the effectiveness of IONM in 300 participants receiving spine surgery. The goal of this study is to refine the alert criteria for procedures in which IONM is used.', 'detailedDescription': 'Intraoperative neurophysiological monitoring (IONM) measures neural function and integrity during surgical procedures. Through IONM, neurodiagnostic procedures can help determine whether any nerves have become compressed or if the brain or spinal cord has any reduced vascular flow, allowing the surgical team to take immediate and corrective actions to prevent a bad outcome. Essentially, IONM acts as an early warning system for surgeons to gain reliable insight into a patient\'s condition during surgery, adding a layer of safety to the measures already in place that monitor cardiac and respiratory function while a patient is anesthetized.\n\nWe propose an observational research study to enhance the evidence-base for IONM. A novel prospective neuromonitoring database will be implemented. In addition to the usual contingency data to assess prediction accuracy, other measures will be examined:\n\n1. A "dose effect of injury" assessment. Three categories of injury will be recorded by physicians: (a) No New Deficit; (b) New Minor Deficit; and (c) New Severe Deficit.\n2. The outcome effect of intraoperative test frequency will be evaluated (infrequent vs average vs very frequent), leading to a "dose effect of neuromonitoring" assessment. Here we hypothesize that within our prospective sample, there is a relationship between the proportion of total new neurological deficits (New Minor Deficit + New Severe Deficit) and the frequency of IONM testing. More frequent testing is associated with fewer total new neurological deficits.\n3. Patient reported outcomes will be evaluated longitudinally in conjunction with clinical outcomes data. Patient interviews will be conducted by a trained research assistant aided by department technologists. Patient-reported neurological outcome assessments will be supplemented/confirmed by review of in- and outpatient surgical/neurophysiologist physician chart notes.\n\nData from this proposed observational study will allow real-life outcomes based improvement in the field of IONM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Anyone 18 or older of any sex undergoing cervical and/or thoracic spine surgical proceudre with intraoperative neuromonitoring at Abbott Northwestern Hospital in Minneapolis, MN', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be 18+ years old\n* Patients must be undergoing cervical and/or thoracic spine surgical procedure at Abbott Northwestern Hospital in Minneapolis, MN\n\nExclusion Criteria:\n\n* Patients who are non-English speakers\n* Patients with ongoing psychiatric concerns are excluded\n* Patients unwilling to be contacted for a 6-month follow-up'}, 'identificationModule': {'nctId': 'NCT05110833', 'acronym': 'IONM', 'briefTitle': 'Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Allina Health System'}, 'officialTitle': 'Dose Responsiveness as a Measure of Clinical Effectiveness During Neuromonitored Spine Surgery', 'orgStudyIdInfo': {'id': '1557758'}}, 'contactsLocationsModule': {'locations': [{'zip': '55447', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Stanley A Skinner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Allina Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allina Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}