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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the SPEAC System to help monitor seizures in veterans. The researchers aim to determine how this device, which uses surface sensors to detect movement during a seizure, affects healthcare usage when used at home. Participants will either continue with their usual care or use the SPEAC System to assess its impact. The trial seeks veterans who experience motor seizures with arm movements and have tried fewer than three seizure medications. As an unphased trial, it offers veterans the chance to contribute to innovative research that could enhance seizure monitoring and healthcare outcomes.

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 prior data suggests that the SPEAC System is safe for seizure monitoring?

Research shows that the SPEAC System is designed to monitor seizures by tracking muscle activity and alerting users to possible seizures. The FDA has approved the system for use by adults at home or in healthcare settings, confirming its safety in these environments.

However, specific safety details from studies on the SPEAC System are not provided. Generally, devices with FDA approval meet certain safety standards, but individual experiences may vary. Prospective trial participants should discuss any concerns with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SPEAC System for seizure monitoring because it offers a new way to track and manage seizures, potentially improving patient outcomes. Unlike traditional methods that rely on patient-reported data or intermittent EEG monitoring, the SPEAC System is a wearable device that continuously monitors brain activity. This real-time data collection can give doctors a more accurate picture of a patient's condition, helping them tailor treatments more precisely. Ultimately, the SPEAC System could lead to more effective seizure management and a better quality of life for patients.

What evidence suggests that the SPEAC System is effective for seizure monitoring?

Research has shown that the SPEAC System, which participants in this trial may receive, effectively monitors seizures, particularly those involving large muscle movements. It sounds an alarm for generalized tonic-clonic (GTC) seizures, characterized by whole-body stiffening and jerking. In real-world use, this system helped change treatment plans for 51.9% of patients by providing detailed data, enabling doctors to adjust medications or make new referrals based on the system's recordings. The SPEAC System is the first of its kind to receive FDA clearance for use in everyday settings. ^{1 4 6 7 8}

Who Is on the Research Team?

Bashir Shihabuddin, MD

Principal Investigator

Central Arkansas VA Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03742661

Impact of SPEAC® System Data on Therapeutic Decisions ... This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and ...

2. neurology.org neurology.org/doi/10.1212/WNL.92.15_supplement.P4.5-012

Real-world use of the SPEAC® System (P4.5-012) The SPEAC System is designed to alarm for Generalized-Tonic Clonic (GTC) seizures, continuously record sEMG data for physicians to review other motor events.

3. withpower.com withpower.com/trial/phase-seizures-10-2018-5fd21

SPEAC System for Seizure Monitoring · Info for Participants The system facilitated significant changes in treatment plans for 51.9% of patients, including adjustments to antiseizure medications and referrals for ...

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf20/K200276.pdf

Brain Sentinel, Inc. Richard Waite Regulatory Consultant 8023 ... The SPEAC® System is intended for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest.

5. epilepsygroup.com epilepsygroup.com/notes6-35-203/the-brain-sentinel-detecting-seizures-anywhere-and-anyt.htm

What is the Brain Sentinel® Monitoring and Alerting System? The SPEAC System is the first non-EEG, physiological, signal-based seizure monitoring system cleared by the FDA. Which patients would benefit from using this ...

6. epilepsy.com epilepsy.com/tools-resources/device-wiki/speac-system

SPEAC System | Device Wiki In February 2017, the SPEAC® System became the first FDA-cleared, non-EEG, physiological, signal-based system for seizure monitoring. Monitoring ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03741192

Impact of SPEAC® System Data on Therapeutic Decisions ... 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 ...

8. files.providernews.anthem.com files.providernews.anthem.com/2013/MED.00130_Pub-01-04-2023.pdf

MED.00130_Pub-01-04-2023.pdf ... SPEAC System has not been established in monitoring sEMG signals that may be associated with seizures other than the GTC seizure. New ...