Trial Outcomes & Findings for EEG Cap for Identification of Non-Convulsive Status Epilepticus (NCT NCT03138876)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

EEG order through 20 minutes of EEG recording time

Results posted on

2019-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	EEG Cap Single arm study, where every participant gets assessed by an electroencephalogram (EEG) cap and then standard EEG. Some subjects may be treated with anti-seizure medications before standard EEG, due to ethical responsibility, if clear Non-convulsive status epilepticus (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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EEG Cap n=20 Participants Single arm study, where every participant gets assessed by an electroencephalogram (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.
Age, Continuous	60.0 years STANDARD_DEVIATION 18.8 • n=20 Participants
Sex: Female, Male Female	9 Participants n=20 Participants
Sex: Female, Male Male	11 Participants n=20 Participants
Region of Enrollment United States	20 Participants n=20 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EEG Cap n=12 Participants Single arm study, where every participant gets assessed by an electroencephalogram (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.
Time Difference Between EEG Cap and Standard EEG Results Reporting	103.4 minutes Standard Deviation 42.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EEG Cap n=20 Participants Single arm study, where every participant gets assessed by an electroencephalogram (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.
Percentage of Participants Whose EEG Cap Recordings Were Interpretable	14 Participants

SECONDARY outcome

Timeframe: approximately within 15 minutes after completion of test

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

Outcome measures

Outcome measures
Measure	EEG Cap n=20 Participants Single arm study, where every participant gets assessed by an electroencephalogram (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.
Number of Subjects Diagnosed With NCSE	3 Participants

SECONDARY outcome

Timeframe: approximately 24 hours after completion of both tests

Concordance between cap and standard-electrode diagnostic assessments

Outcome measures

Outcome measures
Measure	EEG Cap n=20 Participants Single arm study, where every participant gets assessed by an electroencephalogram (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.
Number of Subjects for Which the EEG Cap and Standard EEG Results Are in Agreement for the Diagnosis of NCSE	3 Participants

Adverse Events

EEG Cap

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William O. Tatum

Mayo Clinic

Phone: 904-953-2498

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place