Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Epilepsy Intractable Clinical Trial

Official title:

Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03741192
• Other study ID #: CPT-04-2018
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: January 2026

Study information

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

Clinical Trial Summary

This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: January 2026
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.

2. Subjects suspected of experiencing one or more spells per month.

3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).

4. Male or Female between the ages 22 to 99.

5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.

6. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.

7. Subject or Primary Caregiver must be competent to follow all study procedures.

8. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period (up to five months), for a minimum of 30 hours/ week.

Exclusion Criteria:

1. The subject cannot be pregnant, or nursing.

2. The subject cannot be sensitive or allergic to adhesives or tapes.

3. The subject may not be enrolled in another Clinical Trial.

4. The subject is homeless or in a home without a power supply.

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy Intractable
• Seizures

Intervention

Device:
• SPEAC System
Surface Electromyography (sEMG) based seizure monitoring and alerting system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brain Sentinel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic Impact Form Questionnaire	The physician will complete this questionnaire after each 30 days of device use to determine if information acquired will change the physician's assessment of the patient's seizures and their treatment plan.	Up to 5 months
Secondary	Personal Impact of Epilepsy Scale (PIES) Survey	The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.	1 year
Secondary	VR-12 Survey	This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).	1 year
Secondary	Personal Impact of Epilepsy Scale (PIES) Survey	The PIES survey creates a composite score that can be used to assess the quality of life of patients with epilepsy, as well as sub-scales for assessing the quality of life in specific areas of life with epilepsy.	5 years
Secondary	VR-12 Survey	This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).	5 years
Secondary	VA Administrative Data	Healthcare utilization, medication, and cost data will be collected to determine VA administrative data will be used to evaluate health outcomes.	1 year
Secondary	VA Administrative Data	VA administrative data will be used to evaluate health outcomes.	5 years