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Completed

NCT Number: NCT03138876

EEG Cap for Identification of Non-Convulsive Status Epilepticus

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.

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Key information

Conditions

Nonconvulsive Status Epilepticus Altered Mental Status Brain Diseases Central Nervous System Diseases Encephalopathy Epilepsies, Partial Epilepsy Nervous System Diseases Neurologic Manifestations Nonepileptic Seizures Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Status Epilepticus Subclinical Seizure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

At the completion of neurology evaluation, if NCSE is in the differential diagnosis according to institution best practice, then consented participants will undergo placement of a large size, 20-channel EEG cap from Electro-Cap International with a Natus E-2-2520-26 electrode board adapter with initiation of recording. The placement of the EEG cap will be restricted to residents formally trained in its placement by an EEG tech. This study will only be performed during times when EEG techs are not available onsite for rapid placement of standard 21-channel EEG electrodes, such as during night-call shifts.

Prior to placement of EEG cap, evaluating staff member will request immediate standard-electrode EEG. The investigators will record time from neurology consultation request to placement of EEG cap as well as time from consultation request to obtaining a standard EEG. The investigators will also record time to confirmation or exclusion of NCSE. Initial diagnosis or exclusion of NCSE will be performed by on call resident, if the resident received prior training regarding EEG cap placement, and attending. Secondary quality assessment will be performed by two independent EEG interpreters blinded to clinical history. Secondary assessment will be qualified as acceptable or inacceptable interpretation based on whether greater or less than 50% of the recording is judged interpretable. Secondary assessment will also include interpretation of NCSE by a third independent reader if there is disagreement between first two. The number of patients excluded from the study will also be recorded, including the reason for exclusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

EEG Cap

Device

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

Other names: Electro-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.

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.

Primary outcomes

  1. Time Difference Between EEG Cap and Standard EEG Results Reporting

    Time frame: EEG order through 20 minutes of EEG recording time

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

Secondary outcomes

  1. Percentage of Participants Whose EEG Cap Recordings Were Interpretable

    Time frame: approximately 15 minutes after completion of test

    The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers.

  2. Number of Subjects Diagnosed With NCSE

    Time frame: approximately within 15 minutes after completion of test

    The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG.

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

    Time frame: approximately 24 hours after completion of both tests

    Concordance between cap and standard-electrode diagnostic assessments

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

EEG Cap Placement for Expedited Identification of Non-Convulsive Status Epilepticus

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 3, 2017
Registry last updated
Oct 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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