Novel Epidermal Recording and Detection of Seizures

Seizures Clinical Trial

— NERDS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02451618
• Other study ID #: Epidermal Electronics
• Status: Terminated
• Start date: January 27, 2015

Study information

• Verified date: September 2018
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. primary completion date: November 3, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Asphyxiated Newborn
• Brain Diseases
• Encephalopathy
• Seizures

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Sharp HealthCare	The Gerber Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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. — View 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. — View 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. Erratum in: Science. 2011 Sep 23;333(6050):1703. — View 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. Review. — View 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. — View Citation

Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. Review. — View Citation

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. — View Citation

Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.

Young GB, Campbell VC. EEG monitoring in the intensive care unit: pitfalls and caveats. J Clin Neurophysiol. 1999 Jan;16(1):40-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Apgar scores	Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable	Birth to 10 minutes of life
Other	Subject received hypothermia treatment within 6 hours of life		Within 6 hours of life for 72 hours duration
Other	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.
Other	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.
Other	Gestational age		At birth
Primary	Seizure detection	Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.	24 hours
Secondary	EEG characterization	Compare quality of brain activity with study leads vs standard leads	24 hours
Secondary	Skin integrity from standard EEG vs study electrodes	Photographs will be taken to compare skin integrity after each electrode use.	24 hours
Secondary	Hair removal from standard EEG vs study electrodes	If hair removal is necessary for study electrode placement.	24 hours