EpilepsyNCT03484598
Clinical Utility of the SPEAC® System: A Case Series
A study testing SPEAC System in people with Epilepsy, run by Brain Sentinel at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Epilepsy
- What is being tested?
- SPEAC System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- The subject cannot be pregnant, or nursing.
- The subject cannot be sensitive or allergic to adhesives or tapes.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Austin Epilepsy Care Center
Austin, Texas, 78758
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
The University of South Florida
Tampa, Florida, 33620
About this study
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.
- Conditions
- Epilepsy
- Being tested
- SPEAC System
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPEAC SystemDevice
Also called Brain Sentinel Seizure Monitoring and Alerting System
A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
| Study group | Role | What they receive |
|---|---|---|
| SPEAC Treatment Arm | Experimental | All study participants will be provided with a SPEAC System to use in their home environment. Receives: Device: SPEAC System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Seizure Frequency
We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2019
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484598
- Sponsor's protocol ID
- CS-1.5-01.2018
- Status last verified
- Dec 2019
- First submitted
- 26 Mar 2018
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of the SPEAC® System: A Case Series
- ClinicalTrials.gov ID
- NCT03484598
- Acronym / sponsor ID
- CS-1.5-01.2018
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- Apr 2020 (estimated)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPEAC Treatment Arm | Experimental | Device: SPEAC SystemAll study participants will be provided with a SPEAC System to use in their home environment. |
Who may qualify
- Ages
- 22 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- The subject cannot be pregnant, or nursing.
- The subject cannot be sensitive or allergic to adhesives or tapes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPEAC SystemAlso: Brain Sentinel Seizure Monitoring and Alerting SystemA lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional. | Device | SPEAC Treatment Arm |
Primary outcome
Compare Seizure Frequency
Time frame: 1 year
We will compare self-reported seizure frequency to the seizure frequency measured by the SPEAC System.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPEAC System in people with Epilepsy, run by Brain Sentinel at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare Seizure Frequency (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2019.