Novel Epidermal Recording and Detection of Seizures
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/9/2018 |
| Start Date: | January 27, 2015 |
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.
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.
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.
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.
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
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