Novel Epidermal Recording and Detection of Seizures (NERDS)

A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics

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.

Study Overview

• Status: Terminated
• Conditions: Seizures; Encephalopathy; Asphyxiated Newborn

Detailed Description

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.

EES 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.

Specific Aims:

1. 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.)
2. To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Mary Birch Hospital for Women and Newborns

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Hospitalized neonates who already require continuous EEG recording for clinical care
• Parents signed informed consent
• CGA 44 weeks or less

Exclusion Criteria:

• Patient is moribund

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Epidermal Electronic System; EES, wireless tattoo electrode
Hydrogel electrode; EKG electrode, looking at hairline placement of electrodes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure detection	Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG characterization	Compare quality of brain activity with study leads vs standard leads	24 hours
Skin integrity from standard EEG vs study electrodes	Photographs will be taken to compare skin integrity after each electrode use.	24 hours
Hair removal from standard EEG vs study electrodes	If hair removal is necessary for study electrode placement.	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age		At birth
Apgar scores	Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable	Birth to 10 minutes of life
Subject received hypothermia treatment within 6 hours of life		Within 6 hours of life for 72 hours duration
Cause of seizure if known	Date and time of seizures and etiology	Participants will be followed for the duration of hospital stay, an average of 10 days.
Anticonvulsant medication(s) subject received	Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other	Participants will be followed for the duration of hospital stay, an average of 10 days.

Collaborators and Investigators

• Sponsor: Sharp HealthCare
• Collaborators: The Gerber Foundation
• Investigators: Principal Investigator: Mary J Harbert, MD, Sharp Mary Birch Hospital for Women & Newborns

Publications and helpful links

General Publications

• 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. Erratum In: Science. 2011 Sep 23;333(6050):1703.
• Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.
• Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.
• 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.
• van Rooij LG, Toet MC, van Huffelen AC, Groenendaal F, Laan W, Zecic A, de Haan T, 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.
• 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.
• 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.
• 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.
• Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2015
• Primary Completion (Actual): November 3, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 22, 2015

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Perinatal Depression
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Seizures; Brain Diseases
• Other Study ID Numbers: Epidermal Electronics