Clinical Utility of the SPEAC® System: A Case Series

Brain Sentinel

Status

Unknown

Conditions

Epilepsy

Treatments

Device: SPEAC System

Study type

Interventional

Funder types

Other

Identifiers

NCT03484598

CS-1.5-01.2018

Details and patient eligibility

About

The primary objective is to collect preliminary data related to the clinical utility of the SPEAC System in patients with a history of motor seizures. This trial is primarily an observational investigation. This protocol describes a series of observational case studies. Each case study is intended to be interpreted independent from the other case studies. Self-reported seizure frequency will be compared to observed seizure frequency using the SPEAC System.

Enrollment

26 patients

Sex

All

Ages

22 to 99 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has a reported history of motor seizures (epileptic or not or unknown) with upper extremity motor involvement.
The subject's first reported seizure must be within the last 5 years.
Male or Female between the ages 22 and 99.
If female and of childbearing potential, subject must agree to not become pregnant during the trial.
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.
Subject or Primary Caregiver must be competent to follow all study procedures.
Subject must be willing to use the Seizure Monitoring and Alerting System for a long period of time (up to 90 days), for a minimum of 30 hours/ week.

Exclusion criteria