Clinical Utility of the SPEAC® System: A Case Series

Clinical Utility of the SPEAC® System: A Case Series

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.

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:

• The subject cannot be pregnant, or nursing.
• The subject cannot be sensitive or allergic to adhesives or tapes.