Automated Identification of Psychogenic Nonepileptic Seizures

• Conditions: Convulsion, Non-Epileptic
• Interventions: Device: Brain Sentinel's sEMG Post-processing algorithm

• Registration Number: NCT03013348
• Lead Sponsor: Brain Sentinel

Brief Summary

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

Detailed 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

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2019-05-21
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-18
• Last Update Posted: 2019-12-19
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adolescents (13-21)	Brain Sentinel's sEMG Post-processing algorithm	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.
Children (2-12)	Brain Sentinel's sEMG Post-processing algorithm	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.
Adults (22-99),	Brain Sentinel's sEMG Post-processing algorithm	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.

Primary Outcome Measures

Name	Time	Method
> 70% sensitivity of a post processing method for classification of psychogenic nonepileptic seizures in sEMG artifact captured during vEEG recordings as compared to vEEG interpretation by a panel of three independent Neurologists.	6 months