EpilepsyNCT03742661
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
A study testing SPEAC System in people with Epilepsy, run by Brain Sentinel at 1 site in United States.
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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with… Read more about this study
- Who is it for?
- Ages 22 years and older
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2018to Jan 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
- Male or Female between the ages 22 to 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 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 prolonged period of time (up to 120 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.
- The subject may not be enrolled in another Clinical Trial.
- The subject is homeless or in a home without a power supply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lexington VA Medical Center
Lexington, Kentucky, 40502
About this study
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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.
- 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 Monitoring and Alerting System
Surface Electromyography (sEMG) based seizure monitoring and alerting system
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | SPEAC System Receives: Device: SPEAC System |
| Standard of Care | No intervention | Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 months
Secondary outcomes (6)
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.
Measured: 1 year
VR-12 Survey
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Measured: 1 year
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.
Measured: 5 years
VR-12 Survey
This measure has been used in cost-effectiveness analyses and can be used to calculate quality adjusted life years (QALY).
Measured: 5 years
VA Administrative Data
VA administrative data will be used to evaluate health outcomes.
Measured: 1 year
VA Administrative Data
VA administrative data will be used to evaluate health outcomes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start2 Nov 2018
- Primary completionJan 2021 (estimated)
- Study completionJan 2026 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care. Demographics will be obtained for both groups during this initial clinic visit. The treatment group will be prescribed the Brain Sentinel® SPEAC System for use in the home environment. Study Participants in the standard of care group will be given standard care.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bashir Shihabuddin, MD, Principal investigator, Central Arkansas VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742661
- Sponsor's protocol ID
- CPT-03-2018
- Status last verified
- Jul 2019
- First submitted
- 2 Aug 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patients With a New Diagnosis
- ClinicalTrials.gov ID
- NCT03742661
- Acronym / sponsor ID
- CPT-03-2018
- Conditions
- Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Nov 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.
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 a history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization, taking place in the home setting.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participating physicians will recruit patients meeting the inclusion and exclusion criteria. Upon completion of screening and enrollment procedures study participants will be randomly assigned to one of two groups using a randomized call-in system: treatment or standard of care. Demographics will be obtained for both groups during this initial clinic visit. The treatment group will be prescribed the Brain Sentinel® SPEAC System for use in the home environment. Study Participants in the standard of care group will be given standard care.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: SPEAC SystemSPEAC System |
| Standard of Care | No intervention | –Standard of Care |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Subjects has failed fewer than 3 anti-epileptic drugs (single or combination).
- Male or Female between the ages 22 to 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 legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
Key exclusion criteria (4 listed)
- The subject cannot be pregnant, or nursing.
- The subject cannot be sensitive or allergic to adhesives or tapes.
- The subject may not be enrolled in another Clinical Trial.
- The subject is homeless or in a home without a power supply.
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 Monitoring and Alerting SystemSurface Electromyography (sEMG) based seizure monitoring and alerting system | Device | Treatment Group |
Primary outcome
Diagnostic Impact Form Questionnaire
Time frame: Up to 5 months
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.
6 secondary outcomes
Personal Impact of Epilepsy Scale (PIES) Survey
Time frame: 1 year
VR-12 Survey
Time frame: 1 year
Personal Impact of Epilepsy Scale (PIES) Survey
Time frame: 5 years
VR-12 Survey
Time frame: 5 years
VA Administrative Data
Time frame: 1 year
VA Administrative Data
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
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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.
Bashir Shihabuddin, MD principal investigator
Central Arkansas VA Medical Center
1 site 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 1 site 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 4 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 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Diagnostic Impact Form Questionnaire (time frame: Up to 5 months). 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 10 Jul 2019.