Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:20 AM
Study NCT ID:
NCT07290205
Status:
RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remimazolam NeuroImaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522201', 'term': 'remimazolam'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-15', 'studyFirstSubmitDate': '2025-12-12', 'studyFirstSubmitQcDate': '2025-12-15', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Explicit memory performance', 'timeFrame': 'Day/Visit 2: 12-36 hours after day 1 session', 'description': "Recognition memory testing, using the Remember-Know procedure, in which subjects indicate whether they recognize previously experienced experimental items among novel items (not previously in the experiment). This allows calculation of interdependent measures of recollection \\& familiarity using the signal detection statistic, d'. d' is calculated as the cumulative Gaussian distribution of false positive responses subtracted from the cumulative Gaussian distribution of correctly identified previously-experienced items. d' is on a (theoretically infinite) scale of standard deviation units, with negative values representing performance worse than chance guessing and positive values representing stand deviations of performance above chance. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam."}, {'measure': 'subjective pain ratings', 'timeFrame': 'Day/Visit 1: immediately after no-drug condition MRI scan and immediately after remimazolam condition MRI scan', 'description': 'Numerical ratings of pain intensity and unpleasantness will be obtained after each experimental period involving repeated noxious stimulation. Values will be on a 0-10 scale, with 0 representing none and 10 representing the worst possible rating.'}], 'secondaryOutcomes': [{'measure': 'functional magnetic resonance imaging activation of memory encoding task', 'timeFrame': 'Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan', 'description': 'Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of memory-encoding experimental events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.'}, {'measure': 'functional magnetic resonance imaging activation of the response to noxious stimulation', 'timeFrame': 'Day/Visit 1: during no-drug condition MRI scan and during remimazolam MRI scan', 'description': 'Event-related blood-oxygen level dependent (BOLD) Magnetic Resonance Imaging (MRI) responses will be determined for each experimental item presented, revealing localized changes in blood flow, which correlate to increased neuronal activity. These will be averaged across the multiple repetitions of noxious stimulation events, creating an anatomical map of Z-scores. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.'}, {'measure': 'Functional connectivity', 'timeFrame': 'Day/Visit 1: during no-drug condition MRI scan, during remimazolam MRI scan', 'description': 'Whole-brain functional connectivity will be determined in each condition (no-drug and remimazolam). This generates a matrix of cross-correlation values. Cross-condition comparisons will be the main effect of interest, comparing no drug to remimazolam.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Remimazolam', 'functional MRI', 'electric nerve stimulation', 'sedation', 'functional connectivity', 'memory', 'pain'], 'conditions': ['Anesthesia', 'Pain', 'Remimazolam']}, 'descriptionModule': {'briefSummary': 'This is a single-arm functional MRI study that will determine the effects of remimazolam on cognition and brain activity and connectivity at rest, during noxious stimulation, and during a memory encoding task'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 18-59 years of age, who:\n* have none of the specific exclusion criteria\n* have a valid email address and valid phone number throughout the study\n* free from any non-MRI compatible implants\n\nExclusion Criteria:\n\n* are pregnant or attempting to conceive\n* body mass index (BMI) \\> 35\n* significant memory impairment or hearing loss\n* sleep apnea\n* chronic pain or frequently taking pain medication (including tramadol)\n* chronic medical conditions requiring treatment (hypertension, diabetes, high cholesterol)\n* neurologic disease, including seizures and tremor\n* psychiatric diagnoses, including anxiety, depression, panic, or PTSD\n* a history of any of these medical conditions: abnormal heartbeats (cardiac conduction abnormality or arrhythmia), liver or kidney disease, or significant lung disease\n* severe claustrophobia or MRI intolerance\n* have metal implants or non-removable metal piercings\n* having a history of adverse reaction to midazolam (Versed), lorazepam (Ativan) or another benzodiazepine class medication\n* are allergic to dextran\n* daily alcohol or heavy alcohol use; history of alcohol abuse\n* current daily smoker\n* regular or recent marijuana use (including prescribed/medical marijuana)\n* illicit drug use, i.e., street drugs\n* regularly taking: antiepileptics, antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, or sleep-aids'}, 'identificationModule': {'nctId': 'NCT07290205', 'acronym': 'REMAZ', 'briefTitle': 'Remimazolam NeuroImaging', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Neuroimaging of Sedation With Remimazolam', 'orgStudyIdInfo': {'id': 'STUDY25110017'}, 'secondaryIdInfos': [{'id': 'R35GM146822', 'link': 'https://reporter.nih.gov/quickSearch/R35GM146822', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Remimazolam+Pain', 'description': 'Single-arm study. All subjects receive remimazolam and painful electric nerve stimulation, while being imaged with MRI, as described in the interventions.', 'interventionNames': ['Drug: Remimazolam', 'Device: Peripheral Nerve Stimulation']}], 'interventions': [{'name': 'Remimazolam', 'type': 'DRUG', 'description': 'Subjects in this group will receive an intravenous infusion of this drug, during a portion of the study.', 'armGroupLabels': ['Remimazolam+Pain']}, {'name': 'Peripheral Nerve Stimulation', 'type': 'DEVICE', 'description': 'Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired with a fixed number of the experimental cues, in a pattern that appears random to participants.', 'armGroupLabels': ['Remimazolam+Pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Keith M Vogt, MD, PhD', 'role': 'CONTACT', 'email': 'kev18@pitt.edu', 'phone': '4126473147'}, {'name': 'Keith M. Vogt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'centralContacts': [{'name': 'Keith M Vogt, MD, PhD', 'role': 'CONTACT', 'email': 'kev18@pitt.edu', 'phone': '4126473147'}], 'overallOfficials': [{'name': 'Keith M Vogt, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'After analysis is complete and results have been published, all the above data will be shared in de-identified format, linked together by an assigned subject number.', 'ipdSharing': 'YES', 'description': 'De-identified data to share:\n\n* age, height, weight, sex\n* pain intensity \\& unpleasantness, ratings\n* observer assessment of sedation at the targeted drug dose\n* Behavioral performance data for long-term memory\n* structural and functional MRI images', 'accessCriteria': 'Data will be shared via a publicly-accessible online platform that allows user download at no cost.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keith M Vogt', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of General Medical Sciences (NIGMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Keith M Vogt', 'investigatorAffiliation': 'University of Pittsburgh'}}}}