SeizuresNERDSNCT02451618
Novel Epidermal Recording and Detection of Seizures
An observational study of Seizures and Encephalopathy, run by Sharp HealthCare at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day and older
- Conditions the study is for
- Seizures, Encephalopathy, Asphyxiated Newborn
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2015to 3 Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Hospitalized neonates who already require continuous EEG recording for clinical care
- Parents signed informed consent
- CGA 44 weeks or less
Who cannot join
- Patient is moribund
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
Official title: 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.
Read the 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:
- 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.)
- To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.
- Conditions
- Seizures, Encephalopathy, Asphyxiated Newborn
- Keywords
- Perinatal Depression
- Medical subject headings
- Seizures, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epidermal Electronic System | EES, wireless tattoo electrode | |
| Hydrogel electrode | EKG electrode, looking at hairline placement of electrodes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure detection
Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.
Measured: 24 hours
Secondary outcomes (3)
EEG characterization
Compare quality of brain activity with study leads vs standard leads
Measured: 24 hours
Skin integrity from standard EEG vs study electrodes
Photographs will be taken to compare skin integrity after each electrode use.
Measured: 24 hours
Hair removal from standard EEG vs study electrodes
If hair removal is necessary for study electrode placement.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2015 (estimated)
- Study start27 Jan 2015
- Primary completion3 Nov 2017
Why it stopped: Trial was discontinued due to inadequate signal from study eeg leads.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, M J Harbert, Sharp HealthCare
- Investigators
- Mary J Harbert, MD, Principal investigator, Sharp Mary Birch Hospital for Women & Newborns
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451618
- Sponsor's protocol ID
- Epidermal Electronics
- Acronym
- NERDS
- Status last verified
- Sep 2018
- First submitted
- 31 Mar 2015
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.
PubMed 12060001Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.
PubMed 20727485Isaeva 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.
PubMed 20384780van 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.
PubMed 20100767Nagarajan 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.
PubMed 21723453Ferree 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.
PubMed 11222977Young 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.
PubMed 10082090Kim 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.
PubMed 21836009Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics
- ClinicalTrials.gov ID
- NCT02451618
- Acronym / sponsor ID
- NERDS / Epidermal Electronics
- Conditions
- Seizures, Encephalopathy, Asphyxiated Newborn
- Keywords
- Perinatal Depression
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Trial was discontinued due to inadequate signal from study eeg leads.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 3 Nov 2017 (actual)
- First posted
- 22 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.)
- To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidermal Electronic System | – | –EES, wireless tattoo electrode |
| Hydrogel electrode | – | –EKG electrode, looking at hairline placement of electrodes. |
Who may qualify
- Ages
- 1 day and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Hospitalized neonates who already require continuous EEG recording for clinical care
- Parents signed informed consent
- CGA 44 weeks or less
Key exclusion criteria (1 listed)
- Patient is moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seizure detection
Time frame: 24 hours
Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.
3 secondary outcomes
EEG characterization
Time frame: 24 hours
Skin integrity from standard EEG vs study electrodes
Time frame: 24 hours
Hair removal from standard EEG vs study electrodes
Time frame: 24 hours
Results and safety
The study was stopped early (reason given: Trial was discontinued due to inadequate signal from study eeg leads.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Background: PubMed 12060001Tharp BR. Neonatal seizures and syndromes. Epilepsia. 2002;43 Suppl 3:2-10. doi: 10.1046/j.1528-1157.43.s.3.11.x.
- Background: PubMed 20727485Lawrence R, Inder T. Neonatal status epilepticus. Semin Pediatr Neurol. 2010 Sep;17(3):163-8. doi: 10.1016/j.spen.2010.06.010.
- Background: PubMed 20384780Isaeva 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.
- Background: PubMed 20100767van 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.
- Background: PubMed 21723453Nagarajan 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.
- Background: PubMed 11222977Ferree 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.
- Background: PubMed 10082090Young 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.
- Background: PubMed 21836009Kim 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.
- BackgroundVolpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.
Related trials for Seizures
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Not yet recruitingPhase 4
Study of Electrocardiogram (ECG) Safety of Sezaby in Neonatal Seizures
Neonatal Seizure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mary J Harbert, MD principal investigator
Sharp Mary Birch Hospital for Women & Newborns
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Seizures and Encephalopathy, run by Sharp HealthCare at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Trial was discontinued due to inadequate signal from study eeg leads.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure detection (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02451618, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.