SPEAC System for Seizure Monitoring

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brain Sentinel

Must be taking: Anti-epileptic drugs

Disqualifiers: Pregnancy, Allergies, Homelessness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

5 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, as the focus is on using a seizure monitoring system.

What data supports the effectiveness of the SPEAC System treatment for seizure monitoring?

The research highlights the effectiveness of various seizure monitoring systems, such as a video/audio-based system and a machine learning-based alerting system, which improve seizure detection and monitoring. These systems, similar to the SPEAC System, enhance the accuracy and reliability of seizure monitoring, suggesting potential effectiveness in managing seizures. ^{1 2 3 4 5}

Is the SPEAC System for Seizure Monitoring safe for humans?

The research articles do not provide specific safety data for the SPEAC System for Seizure Monitoring. They discuss general safety concerns and needs for seizure detection devices, but no direct safety information about the SPEAC System itself is available. ^{6 7 8 9 10}

How does the SPEAC System treatment for seizure monitoring differ from other treatments?

The SPEAC System is unique because it offers a non-invasive, long-term seizure monitoring solution that can be used at home, unlike traditional EEG monitoring which is uncomfortable and typically done in a hospital setting. It focuses on detecting seizures through body signals rather than brain waves, making it more user-friendly and suitable for continuous use. ^{5 11 12 13 14}

What is the purpose of this trial?

This trial tests a device that monitors muscle activity to detect seizures in veterans with arm-involved motor seizures. The device alerts users when it detects unusual muscle movements, helping to identify seizures.

Research Team

Bashir Shihabuddin, MD

Principal Investigator

Central Arkansas VA Medical Center

Eligibility Criteria

This trial is for veterans aged 22-99 with a history of motor seizures, who can consent to the study and commit to using the SPEAC System for up to 120 days. They must be able to follow procedures and use the system for at least 30 hours per week. It's not open to those in other trials, pregnant or nursing women, individuals allergic to adhesives or tapes, or without home power supply.

Inclusion Criteria

I have tried less than 3 epilepsy medications without success.

I or my caregiver can follow all study instructions.

I am a veteran with a history of seizures affecting my arms, and my seizure type is unclear.

Exclusion Criteria

The subject cannot be pregnant, or nursing.

The subject may not be enrolled in another Clinical Trial.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the SPEAC System for seizure monitoring and alerting

5 months

Monthly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term monitoring

Long-term evaluation of health outcomes using VA administrative data and surveys

5 years

Treatment Details

Interventions

• SPEAC System

Trial Overview The SPEAC System is being tested; it's an sEMG-based seizure monitoring device that alerts users about convulsive seizures. This study aims to see how this technology affects healthcare decisions and management for veterans with epilepsy in their homes.

Participant Groups

Group I: Treatment Group Experimental Treatment 1 Intervention

SPEAC System

Group II: Standard of Care Active Control 1 Intervention

Standard of Care

Who Is Running the Clinical Trial?

Brain Sentinel

Lead Sponsor

Trials

11

Recruited

640+

Findings from Research

The Nelli® hybrid video/audio monitoring system successfully identified clinically relevant events in 80% of the 104 patients studied, capturing 2767 epileptic seizures and aiding in clinical decision-making for therapeutic interventions in 68% of cases.

The system facilitated significant changes in treatment plans for 51.9% of patients, including adjustments to antiseizure medications and referrals for presurgical evaluations, demonstrating its effectiveness in optimizing seizure management in a home setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical utility of a video/audio-based epilepsy monitoring system Nelli. Basnyat, P., Mäkinen, J., Saarinen, JT., et al.[2022]

In a study evaluating four non-EEG seizure monitoring systems for a patient with focal epilepsy, the Emfit mat demonstrated the highest sensitivity (78%) and low false detection rate (0.55 per night), making it the most effective choice for home monitoring.

While some devices showed promising results, they often missed specific seizure types, highlighting the need for personalized assessments and a comprehensive database to guide the selection of monitoring systems based on individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Critical evaluation of four different seizure detection systems tested on one patient with focal and generalized tonic and clonic seizures. Van de Vel, A., Verhaert, K., Ceulemans, B.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Standardization of seizure response times and data collection in an epilepsy monitoring unit. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical utility of a video/audio-based epilepsy monitoring system Nelli. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A Full-Stack Application for Detecting Seizures and Reducing Data During Continuous Electroencephalogram Monitoring. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Real-time multi-channel monitoring of burst-suppression using neural network technology during pediatric status epilepticus treatment. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Seizure moitoring: a new tool in electroencephalography. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Kathleen Mears Memorial Lecture: An update on patient safety issues in the epilepsy monitoring unit. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Seizure detection devices: A survey of needs and preferences of patients and caregivers. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Seizure detection at home: Do devices on the market match the needs of people living with epilepsy and their caregivers? [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Sensitivity of a seizure activity detection computer in childhood video/electroencephalographic monitoring. [2019]

10. Australia pubmed.ncbi.nlm.nih.gov

Evaluation of an E-learning resource on approach to the first unprovoked seizure. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Non-EEG seizure-detection systems and potential SUDEP prevention: state of the art. [2014]

12. United States pubmed.ncbi.nlm.nih.gov

Critical evaluation of four different seizure detection systems tested on one patient with focal and generalized tonic and clonic seizures. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

A Resource-Optimized VLSI Implementation of a Patient-Specific Seizure Detection Algorithm on a Custom-Made 2.2 cm 2 Wireless Device for Ambulatory Epilepsy Diagnostics. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Multi-modal intelligent seizure acquisition (MISA) system--a new approach towards seizure detection based on full body motion measures. [2020]