Automated Identification of Psychogenic Nonepileptic Seizures

Convulsion, Non-Epileptic Clinical Trial

Official title:

Automated Identification of Psychogenic Nonepileptic Seizures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03013348
• Other study ID #: NES-1.5-09.2016
• Status: Active, not recruiting
• Start date: January 2017
• Est. completion date: August 2020

Study information

• Verified date: December 2019
• Source: Brain Sentinel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 104
• Est. completion date: August 2020
• Est. primary completion date: May 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Convulsion, Non-Epileptic
• Seizures

Intervention

Device:
• Brain Sentinel's sEMG Post-processing algorithm
Brain Sentinel has developed a post processing method that identifies sEMG signals (recorded from the biceps brachii or as muscle artifact in electroencephalography [EEG] recordings) that are pathognomonic for PNES activity.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	> 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