Ignite Creation Date:
2025-12-24 @ 2:46 PM
Ignite Modification Date:
2025-12-25 @ 3:29 PM
Study NCT ID:
NCT01648959
Status:
TERMINATED
Last Update Posted:
2022-12-22
First Post:
2012-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intra Cranial EEG Activity During Dexmedetomidine Sedation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'emad.alazazi@uhnresearch.ca', 'phone': '416-603-8500', 'title': 'Emad Al Azazi', 'phoneExt': '6237', 'organization': 'Toronto Western Hospital/UHN'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From the time of induction to the end of surgical procedure', 'description': 'No adverse events reported', 'eventGroups': [{'id': 'EG000', 'title': 'iEEG Activity', 'description': 'iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'iEEG Recording', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'iEEG Activity', 'description': 'Data are presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '10'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'iEEG data from each patient was analyzed using MATLAB (Natick, MA, USA). Data were presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal. The spectrogram is a time-varying version of the spectrum. In these spectrograms, frequencies are arranged along the y-axis, and time along the x-axis, and power is indicated by color on a decibel (dB) scale. The power spectrum was computed for each channel using The Fast Fourier Transform (FFT). A window length of 20,000 data points was chosen in order to incorporate 4 cycles of a 1 Hz signal. The length of each window was therefore 4 seconds. A Hanning window was used to avoid edge effects of the windowing procedure. The length of the FFT was chosen to be 32768, which is the next power of 2 of the window length. The window overlap was set to zero.', 'unitOfMeasure': '(Hz)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'iEEG Activity', 'description': 'iEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Dexmedetomidine Infusion and iEEG Activity', 'description': '5 patients included in this study underwent bi-temporal implantation, and were shown to have unilateral hippocampal seizure onsets.\n\niEEG data acquires every minute from the start of dexmedetomidine infusion to 5 minutes after the bolus dose.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '37.3', 'spread': '7.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': '5 patients who underwent elective removal of intracranial (neocortical and depth) electrodes under dexmedetomidine sedation were recruited for this prospective, non-randomized, observational study'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2012-07-13', 'resultsFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2012-07-23', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-05', 'studyFirstPostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iEEG Recording', 'timeFrame': '1 day', 'description': 'iEEG data from each patient was analyzed using MATLAB (Natick, MA, USA). Data were presented as power spectral density, also referred to as the power spectrum or spectrum which quantifies the frequency distribution of energy or power within a signal. The spectrogram is a time-varying version of the spectrum. In these spectrograms, frequencies are arranged along the y-axis, and time along the x-axis, and power is indicated by color on a decibel (dB) scale. The power spectrum was computed for each channel using The Fast Fourier Transform (FFT). A window length of 20,000 data points was chosen in order to incorporate 4 cycles of a 1 Hz signal. The length of each window was therefore 4 seconds. A Hanning window was used to avoid edge effects of the windowing procedure. The length of the FFT was chosen to be 32768, which is the next power of 2 of the window length. The window overlap was set to zero.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complex Partial Seizures']}, 'descriptionModule': {'briefSummary': 'Various parts of the brain are sensitive to various anesthetics.We like to study the effect of dexmedetomidine on the different parts of the brain in patients who are coming for DBS electrode removal under sedation.', 'detailedDescription': 'Cortical and sub cortical structures will have different sensitivities to various anesthetics.The objective of this study is to look at the changes in the intracranial electroencephalographic (EEG) characteristics during dexmedetomidine sedation and to determine the differences in the EEG characteristics between cortical and subcortical structures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18 to 80 years of age, who are scheduled for elective removal of intracranial (surface and depth) electrodes under conscious sedation\n\nExclusion Criteria:\n\n* Lack of informed consent\n* Hypersensitivity to dexmedetomidine\n* Language barrier\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT01648959', 'briefTitle': 'Intra Cranial EEG Activity During Dexmedetomidine Sedation', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Intra Cranial EEG Activity During Dexmedetomidine Sedation.Comparing the Effects of Dexmedetomidine on the Cortical and the Sub Cortical(Hippocampus) Structures.', 'orgStudyIdInfo': {'id': '12-0268'}}, 'armsInterventionsModule': {'interventions': [{'name': 'EEG Recording', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5T2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital,UHN.', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'lashmikumar venkatraghavan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor,Toronto western hospital,university health network (UHN)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Lashmi Venkatraghavan', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}