Encephalopathy Clinical Trial
Official title:
EEG Cap Placement for Expedited Identification of Non-Convulsive Status Epilepticus
NCT number | NCT03138876 |
Other study ID # | 16-008778 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 30, 2017 |
Est. completion date | August 16, 2018 |
Verified date | October 2019 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 16, 2018 |
Est. primary completion date | August 16, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
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. Review. Erratum in: Brain. 2013 Jul;136(Pt 7):2326. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | approximately 15 minutes after completion of test | |
Secondary | Number of Subjects Diagnosed With NCSE | The number of subjects with suspected NCSE subsequently confirmed with NCSE after standard EEG. | approximately within 15 minutes after completion of test | |
Secondary | 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 | approximately 24 hours after completion of both tests |
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