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EEG Cap for Identification of Non-Convulsive Status Epilepticus

Primary Purpose

Nonconvulsive Status Epilepticus, Subclinical Seizure, Altered Mental Status

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EEG Cap
Anti-seizure medication
Standard EEG
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Nonconvulsive Status Epilepticus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

  1. Patients younger than 18 years of age.
  2. Patients with open head trauma.
  3. Patients with anatomy that would preclude EEG cap placement.
  4. 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.
  5. Pregnant females
  6. Large head size not amenable to cap placement
  7. Scalp infection
  8. Inability to obtain informed consent

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EEG Cap

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Whose EEG Cap Recordings Were Interpretable
The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers.
Number of Subjects Diagnosed With NCSE
The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG.
Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE
Concordance between cap and standard-electrode diagnostic assessments

Full Information

First Posted
May 1, 2017
Last Updated
October 4, 2019
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03138876
Brief Title
EEG Cap for Identification of Non-Convulsive Status Epilepticus
Official Title
EEG Cap Placement for Expedited Identification of Non-Convulsive Status Epilepticus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
August 16, 2018 (Actual)
Study Completion Date
August 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonconvulsive Status Epilepticus, Subclinical Seizure, Altered Mental Status, Nonepileptic Seizures, Encephalopathy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
There will be blinded EEG assessment in terms of the EEG readers.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EEG Cap
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EEG Cap
Other Intervention Name(s)
Electro-Cap
Intervention Description
Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE.
Intervention Type
Drug
Intervention Name(s)
Anti-seizure medication
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard EEG
Intervention Description
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 Outcome Measure Information:
Title
Time Difference Between EEG Cap and Standard EEG Results Reporting
Description
The difference between EEG Cap results reporting time compared to Standard EEG results reporting time measured in minutes.
Time Frame
EEG order through 20 minutes of EEG recording time
Secondary Outcome Measure Information:
Title
Percentage of Participants Whose EEG Cap Recordings Were Interpretable
Description
The recording will be qualified as acceptable interpretation if greater than 50% of the recording is judged interpretable by board certified electroencephalographers.
Time Frame
approximately 15 minutes after completion of test
Title
Number of Subjects Diagnosed With NCSE
Description
The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG.
Time Frame
approximately within 15 minutes after completion of test
Title
Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE
Description
Concordance between cap and standard-electrode diagnostic assessments
Time Frame
approximately 24 hours after completion of both tests

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Tatum
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22577217
Citation
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. Erratum In: Brain. 2013 Jul;136(Pt 7):2326.
Results Reference
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EEG Cap for Identification of Non-Convulsive Status Epilepticus

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