Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 12:29 AM
Study NCT ID:
NCT05435560
Status:
UNKNOWN
Last Update Posted:
2022-06-28
First Post:
2022-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurochemical Mechanisms of the Awake vs. Anesthetized Brain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-23', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-06-23', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain positron emission tomography (PET) imaging signals.', 'timeFrame': '2 hours', 'description': 'Changes in dopamine receptor availability will be quantified from brain PET images.'}, {'measure': 'Functional magnetic resonance imaging (fMRI) signals.', 'timeFrame': '2 hours', 'description': 'fMRI measures of hemodynamic responses.'}, {'measure': 'Differences in electroencephalography (EEG) measures between arousal and anesthesia.', 'timeFrame': '2 hours', 'description': 'Arousal states will be characterized from changes in the EEG power spectrum.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '2 hours', 'description': 'Heart rate variability.'}, {'measure': 'Pulse oximetry', 'timeFrame': '2 hours', 'description': 'Amplitude of pulse oximetry signal.'}, {'measure': 'Respiratory physiology', 'timeFrame': '2 hours', 'description': 'Breathing rate (breaths per minute).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dopamine', 'Anesthesia', 'Positron Emission Tomography', 'Magnetic Resonance Imaging', 'Electroencephalograpy', 'Sleep'], 'conditions': ['Anesthesia', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The investigators will be studying the sedative drug dexmedetomidine using hybrid PET/fMRI/EEG imaging to better understand the neuropharmacology of anesthesia/artificially induced sleep.', 'detailedDescription': 'A group of healthy volunteers will undergo simultaneous PET/fMRI/EEG imaging under two different conditions: while being administered a sedative (dexmedetomidine), and while being administered a normal saline infusion, as a control. The order of these two scans will be randomized, and the study design is open label (ie subjects and investigators know which session will be the control scan and which one will be the sedative scan). Investigators hope that by comparing the results of the sedative and control scans, the different neuromodulatory states involved in the transition from wakefulness to medically induced vs naturally occurring sleep can be better understood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18-45.\n* No contraindications to MRI or PET scanning.\n\nExclusion Criteria:\n\n* Contraindications to fMRI scanning and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);\n* Pregnancy or breast feeding;\n* Current or past history of major medical, neurological, or psychiatric condition;\n* History of major head trauma;\n* Any cardiovascular disorders, including heart disorders or high blood pressure \\[\\>155/95\\];\n* Breathing problems such as severe asthma;\n* Bleeding disorder, or use of anticoagulants;\n* Bladder obstruction, urinary problems, or history of impaired elimination;\n* Known kidney or liver problems;\n* Intestinal blockage;\n* Raynaud syndrome\n* Peripheral nerve injury;\n* Diabetes;\n* Glaucoma;\n* Sleep disorder, such as sleep apnea, insomnia, or narcolepsy\n* Current use of any drugs that affect sleep\n* Current or recent use of medications (neurological or psychiatric) affecting brain function\n* Current or past history of chronic pain (assessed at discretion of PI);\n* History of allergic reactions\n* History of chronic obstructive pulmonary diseases\n* Ulcerative skin conditions or other dermatologic conditions which could interfere with blood pressure cuff placement\n* Body mass index above 30\n* Current smoker\n* Lack of current health insurance coverage\n* Employed under the direct supervision of the investigators conducting the research\n* Hair in dreadlocks, twists, or braids that cannot be removed\n* Eczema on the scalp or face'}, 'identificationModule': {'nctId': 'NCT05435560', 'briefTitle': 'Neurochemical Mechanisms of the Awake vs. Anesthetized Brain', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Characterizing the Neuropharmacology of Dexmedetomidine Through Trimodal Imaging', 'orgStudyIdInfo': {'id': '2021P003426'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine', 'description': 'During the imaging scan subjects will receive an initial 1µg/kg bolus of dexmedetomidine up to a maximum dose of 80 µg, infused through IV over 10 minutes. After the bolus has been administered, a constant infusion of up to 0.6 µg/kg/hr (0.01 µg/kg/min) of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes).', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'A saline infusion will be used as a placebo comparator for the dexmedetomidine infusion. It will be administered in the same manner and dosages as the dexmedetomidine.', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['Precedex'], 'description': 'During the imaging scan subjects will receive an initial bolus of dexmedetomidine over 10 minutes. After the bolus has been administered, a constant infusion of dexmedetomidine will be maintained for the remainder of the scan (about 60 minutes).', 'armGroupLabels': ['Dexmedetomidine']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'During the imaging scan subjects will receive an initial bolus of saline over 10 minutes. After the bolus has been administered, a constant infusion of saline will be maintained for the remainder of the scan (about 60 minutes).', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02129', 'city': 'Charlestown', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Irena Bass', 'role': 'CONTACT', 'email': 'ibass@mgh.harvard.edu', 'phone': '617-726-9034'}, {'name': 'Christin Sander, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Athinoula A. Martinos Center for Biomedical Imaging', 'geoPoint': {'lat': 42.37787, 'lon': -71.062}}], 'centralContacts': [{'name': 'Irena Bass, BA', 'role': 'CONTACT', 'email': 'ibass@mgh.harvard.edu', 'phone': '617-726-9034'}, {'name': 'Christin Y Sander, PhD', 'role': 'CONTACT', 'email': 'csander@mgh.harvard.edu', 'phone': '617-726-9034'}], 'overallOfficials': [{'name': 'Christin Y Sander, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Athinoula A. Martinos Center for Biomedical Imaging'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Boston University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Christin Sander, Assistant Professor', 'investigatorFullName': 'Christin Y. Sander, PhD', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}