Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-04-15 @ 8:26 AM
Study NCT ID:
NCT02451618
Status:
TERMINATED
Last Update Posted:
2018-09-07
First Post:
2015-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Novel Epidermal Recording and Detection of Seizures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}, {'id': 'D001927', 'term': 'Brain Diseases'}], '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'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Trial was discontinued due to inadequate signal from study eeg leads.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'lastUpdateSubmitDate': '2018-09-05', 'studyFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2015-05-21', 'lastUpdatePostDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Apgar scores', 'timeFrame': 'Birth to 10 minutes of life', 'description': 'Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable'}, {'measure': 'Subject received hypothermia treatment within 6 hours of life', 'timeFrame': 'Within 6 hours of life for 72 hours duration'}, {'measure': 'Cause of seizure if known', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an average of 10 days.', 'description': 'Date and time of seizures and etiology'}, {'measure': 'Anticonvulsant medication(s) subject received', 'timeFrame': 'Participants will be followed for the duration of hospital stay, an average of 10 days.', 'description': 'Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other'}, {'measure': 'Gestational age', 'timeFrame': 'At birth'}], 'primaryOutcomes': [{'measure': 'Seizure detection', 'timeFrame': '24 hours', 'description': 'Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.'}], 'secondaryOutcomes': [{'measure': 'EEG characterization', 'timeFrame': '24 hours', 'description': 'Compare quality of brain activity with study leads vs standard leads'}, {'measure': 'Skin integrity from standard EEG vs study electrodes', 'timeFrame': '24 hours', 'description': 'Photographs will be taken to compare skin integrity after each electrode use.'}, {'measure': 'Hair removal from standard EEG vs study electrodes', 'timeFrame': '24 hours', 'description': 'If hair removal is necessary for study electrode placement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Perinatal Depression'], 'conditions': ['Seizures', 'Encephalopathy', 'Asphyxiated Newborn']}, 'referencesModule': {'references': [{'pmid': '12060001', 'type': 'BACKGROUND', 'citation': 'Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.'}, {'pmid': '20727485', 'type': 'BACKGROUND', 'citation': 'Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.'}, {'pmid': '20384780', 'type': 'BACKGROUND', 'citation': 'Isaeva E, Isaev D, Savrasova A, Khazipov R, Holmes GL. Recurrent neonatal seizures result in long-term increases in neuronal network excitability in the rat neocortex. Eur J Neurosci. 2010 Apr;31(8):1446-55. doi: 10.1111/j.1460-9568.2010.07179.x. Epub 2010 Apr 6.'}, {'pmid': '20100767', 'type': 'BACKGROUND', 'citation': 'van Rooij LG, Toet MC, van Huffelen AC, Groenendaal F, Laan W, Zecic A, de Haan TR, van Straaten IL, Vrancken S, van Wezel G, van der Sluijs J, Ter Horst H, Gavilanes D, Laroche S, Naulaers G, de Vries LS. Effect of treatment of subclinical neonatal seizures detected with aEEG: randomized, controlled trial. Pediatrics. 2010 Feb;125(2):e358-66. doi: 10.1542/peds.2009-0136. Epub 2010 Jan 25.'}, {'pmid': '21723453', 'type': 'BACKGROUND', 'citation': 'Nagarajan L, Ghosh S, Palumbo L. Ictal electroencephalograms in neonatal seizures: characteristics and associations. Pediatr Neurol. 2011 Jul;45(1):11-6. doi: 10.1016/j.pediatrneurol.2011.01.009.'}, {'pmid': '11222977', 'type': 'BACKGROUND', 'citation': 'Ferree TC, Luu P, Russell GS, Tucker DM. Scalp electrode impedance, infection risk, and EEG data quality. Clin Neurophysiol. 2001 Mar;112(3):536-44. doi: 10.1016/s1388-2457(00)00533-2.'}, {'pmid': '10082090', 'type': 'BACKGROUND', 'citation': 'Young GB, Campbell VC. EEG monitoring in the intensive care unit: pitfalls and caveats. J Clin Neurophysiol. 1999 Jan;16(1):40-5. doi: 10.1097/00004691-199901000-00003.'}, {'pmid': '21836009', 'type': 'BACKGROUND', 'citation': 'Kim DH, Lu N, Ma R, Kim YS, Kim RH, Wang S, Wu J, Won SM, Tao H, Islam A, Yu KJ, Kim TI, Chowdhury R, Ying M, Xu L, Li M, Chung HJ, Keum H, McCormick M, Liu P, Zhang YW, Omenetto FG, Huang Y, Coleman T, Rogers JA. Epidermal electronics. Science. 2011 Aug 12;333(6044):838-43. doi: 10.1126/science.1206157.'}, {'type': 'BACKGROUND', 'citation': 'Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.'}]}, 'descriptionModule': {'briefSummary': 'For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.', 'detailedDescription': 'Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.\n\nEES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.\n\nSpecific Aims:\n\n1. To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)\n2. To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Day', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Any newborn admitted to the NICU that requires an EEG for clinical care. Must be less than or equal to 44 weeks corrected gestational age.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized neonates who already require continuous EEG recording for clinical care\n* Parents signed informed consent\n* CGA 44 weeks or less\n\nExclusion Criteria:\n\n* Patient is moribund'}, 'identificationModule': {'nctId': 'NCT02451618', 'acronym': 'NERDS', 'briefTitle': 'Novel Epidermal Recording and Detection of Seizures', 'organization': {'class': 'OTHER', 'fullName': 'Sharp HealthCare'}, 'officialTitle': 'A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics', 'orgStudyIdInfo': {'id': 'Epidermal Electronics'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidermal Electronic System', 'description': 'EES, wireless tattoo electrode'}, {'label': 'Hydrogel electrode', 'description': 'EKG electrode, looking at hairline placement of electrodes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Mary Birch Hospital for Women and Newborns', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Mary J Harbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharp Mary Birch Hospital for Women & Newborns'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharp HealthCare', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Gerber Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Neonatal Neurology', 'investigatorFullName': 'M J Harbert', 'investigatorAffiliation': 'Sharp HealthCare'}}}}