Automated Identification of Psychogenic Nonepileptic Seizures

Brain Sentinel

Status: Unknown

Conditions: Convulsion, Non-Epileptic

Treatments: Device: Brain Sentinel's sEMG Post-processing algorithm

Study type: Observational

Funder types: Other

Identifiers

NCT03013348

NES-1.5-09.2016

Details and patient eligibility

About

A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures

Full description

This is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (sEMG) artifact previously recorded during routine video-electroencephalographic (vEEG) monitoring

Enrollment: 104 patients

Sex: All

Ages: 2 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

A subject will be eligible for inclusion in this study if the following criteria apply.

• Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission.
• Male or female between the ages of 2-99
• 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

Exclusion criteria

• No exclusion criteria have been established for this study.

Trial design

104 participants in 3 patient groups

Adults (22-99),

Description:

Male or female subject between the ages of 22-99, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group.

Treatment:

Device: Brain Sentinel's sEMG Post-processing algorithm

Adolescents (13-21)

Description:

Male or female subject between the ages of 13-21, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group.

Treatment:

Device: Brain Sentinel's sEMG Post-processing algorithm

Children (2-12)

Description:

Male or female subject between the ages of 2-12, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group.

Treatment:

Device: Brain Sentinel's sEMG Post-processing algorithm