Detecting PNES With Single-channel sEMG

Brain Sentinel

Status: Unknown

Conditions: Psychogenic Seizures; Epilepsy, Motor Partial

Treatments: Device: SPEAC System; Device: video EEG

Study type: Interventional

Funder types: Other

Identifiers

NCT03313362

PNES-1.5-01.2017

Details and patient eligibility

About

This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.

Enrollment: 71 patients

Sex: All

Ages: 22 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
2. Is being admitted to a hospital for routine vEEG monitoring related to seizures.
3. Male or Female between the ages 22 to 99.
4. If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
5. Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
6. Subject and/or Primary Caregiver must be competent to follow all study procedures.
7. Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.

Exclusion criteria

• Intracranial EEG electrodes are being used.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Subjects admitted to Epilepsy Monitoring Units in the VAMC

Experimental group

Description:

Subjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System).

Treatment:

Device: video EEG

Device: SPEAC System