EEG Cap for Identification of Non-Convulsive Status Epilepticus

NCT03138876 | Completed Results FDA Device

• 1 other identifier: 16-008778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Altered mental status (AMS) is one of the most common reasons for inpatient neurology consultation. Non-convulsive status epilepticus (NCSE) is frequently on the differential diagnosis of the patient with AMS. NCSE becomes more refractory to treatment after one hour of seizure activity, making rapid identification and treatment of NCSE of great clinical importance. Currently, an electroencephalogram (EEG) technologist must be called in from home during non-workday hours in order to obtain a stat EEG. The investigators propose the time required for diagnosis of NCSE at Mayo Clinic can be significantly decreased with rapid placement of an EEG cap by the onsite neurology residents.

Conditions

Nonconvulsive Status Epilepticus; Subclinical Seizure; Altered Mental Status; Nonepileptic Seizures; Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Time Difference Between EEG Cap and Standard EEG Results Reporting

  The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes.

  EEG order through 20 minutes of EEG recording time

Secondary Outcomes (3)

• Percentage of Participants Whose EEG Cap Recordings Were Interpretable

  approximately 15 minutes after completion of test

• Number of Subjects Diagnosed With NCSE

  approximately within 15 minutes after completion of test

• Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE

  approximately 24 hours after completion of both tests

Study Arms (1)

EEG Cap

OTHER

Single arm study, where every participant gets assessed by EEG cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear NCSE is identified on cap EEG. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

Device: EEG Cap; Drug: Anti-seizure medication; Procedure: Standard EEG

Interventions

EEG Cap DEVICE

Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE.

Also known as: Electro-Cap

EEG Cap

Anti-seizure medication DRUG

Patients may be treated for NCSE or seizures based on EEG cap findings, if the findings are clear to an attending EEG reviewer. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.

EEG Cap

Standard EEG PROCEDURE

An electroencephalogram (EEG) is a test used to find problems related to electrical activity of the brain. An EEG tracks and records brain wave patterns. Small metal discs with thin wires (electrodes) are placed on the scalp, and then send signals to a computer to record the results.

EEG Cap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspected NCSE in the Mayo Clinic Florida hospital, emergency room or intensive care unit.
• Age: Patients of 18 years or older will be included in this study
• Education: All education levels will be included

You may not qualify if:

• Patients younger than 18 years of age.
• Patients with open head trauma.
• Patients with anatomy that would preclude EEG cap placement.
• Patients excluded for anatomical or age-related reasons will be tracked to determine applicability of the EEG cap to the patient population at Mayo Clinic.
• Pregnant females
• Large head size not amenable to cap placement
• Scalp infection
• Inability to obtain informed consent

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Publications (1)

• Ferlisi M, Shorvon S. The outcome of therapies in refractory and super-refractory convulsive status epilepticus and recommendations for therapy. Brain. 2012 Aug;135(Pt 8):2314-28. doi: 10.1093/brain/aws091. Epub 2012 May 9.

  PMID: 22577217 BACKGROUND

MeSH Terms

Conditions

Status Epilepticus; Epilepsies, Partial; Seizures; Brain Diseases

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy; Central Nervous System Diseases

Results Point of Contact

• Title: Dr. William O. Tatum
• Organization: Mayo Clinic

tatum.william@mayo.edu

904-953-2498

Study Officials

• William Tatum

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: There will be blinded EEG assessment in terms of the EEG readers.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Model Details: Subjects may be treated for NCSE based on EEG cap findings, but only following standard practice. The study is designed to identify NCSE, not to assess treatment of NCSE.

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: May 30, 2017
• Primary Completion: August 16, 2018
• Study Completion: August 16, 2018
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)