Epilepsy, Motor PartialNCT03313362
Detecting PNES With Single-channel sEMG
A study testing SPEAC System and video EEG in people with Epilepsy, Motor Partial and Psychogenic Seizures, run by Brain Sentinel at 3 sites in United States.
Trial summary
This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers. Read more about this study
- Who is it for?
- Ages 22 to 99 years
- Conditions the study is for
- Epilepsy, Motor Partial, Psychogenic Seizures
- What is being tested?
- SPEAC System and video EEG
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Nov 2017to Feb 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 history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or Female between the ages 22 to 99.
- If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
- 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 and/or Primary Caregiver must be competent to follow all study procedures.
- Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.
Who cannot join
- Intracranial EEG electrodes are being used.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Durham VAMC
Durham, North Carolina, 27705
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.
- Conditions
- Epilepsy, Motor Partial, Psychogenic Seizures
- Being tested
- SPEAC System, video EEG
- Medical subject headings
- Epilepsy, Partial, Motor, Psychogenic Nonepileptic Seizures
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
Seizure Monitoring and Alerting System
video EEGDevice
The Video EEG Monitoring Test (VEEG) is a high specialized form of an EEG test in where the patient is continuosly monitored by using a video recorder. This allows doctors to observe brainwaves activity during the time a seizure or spell is occurring.
| Study group | Role | What they receive |
|---|---|---|
| Subjects admitted to Epilepsy Monitoring Units in the VAMC | Experimental | Subjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System). Receives: Device: SPEAC System; Device: video EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
To test the null hypothesis that three independent epileptologists categorize, by majority vote, epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases using sEMG and audio. We aim to test the null hypothesis that the epileptologists categorize epileptic seizures and psychogenic non-epileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test.
Measured: 1 year
Secondary outcomes (1)
To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.
Test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System categorizes epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases. We aim to test the null hypothesis that the Brain Sentinel® Seizure Monitoring and Alerting System's software categorizes epileptic seizures and psychogenic Nonepileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test.
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 posted18 Oct 2017
- Study start3 Nov 2017
- Primary completion21 Jun 2019
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Motor PartialStudies 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aatif Husain, MD, Principal investigator, Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North CarolinaAlan Towne, MD, Principal investigator, Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, VirginiaDavid Chen, MD, Principal investigator, Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03313362
- Sponsor's protocol ID
- PNES-1.5-01.2017
- Status last verified
- Dec 2019
- First submitted
- 10 Oct 2017
- Last updated
- 20 Dec 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting PNES With Single-channel sEMG
- ClinicalTrials.gov ID
- NCT03313362
- Acronym / sponsor ID
- PNES-1.5-01.2017
- Conditions
- Epilepsy, Motor Partial, Psychogenic Seizures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Oct 2017 (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 a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects admitted to Epilepsy Monitoring Units in the VAMC | Experimental | Device: SPEAC System, Device: video EEGSubjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System). |
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 history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or Female between the ages 22 to 99.
- If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
- 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 (1 listed)
- Intracranial EEG electrodes are being used.
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 SystemSeizure Monitoring and Alerting System | Device | Subjects admitted to Epilepsy Monitoring Units in the VAMC |
| video EEGThe Video EEG Monitoring Test (VEEG) is a high specialized form of an EEG test in where the patient is continuosly monitored by using a video recorder. This allows doctors to observe brainwaves activity during the time a seizure or spell is occurring. | Device | Subjects admitted to Epilepsy Monitoring Units in the VAMC |
Primary outcome
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
Time frame: 1 year
To test the null hypothesis that three independent epileptologists categorize, by majority vote, epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases using sEMG and audio. We aim to test the null hypothesis that the epileptologists categorize epileptic seizures and psychogenic non-epileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test.
1 secondary outcome
To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.
Time frame: 1 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
Related trials for Epilepsy, Motor Partial
RecruitingObservational study
Integrating Metabolism, Connectivity, and Mesoscale Imaging at Ultra-high Field to Decipher Mechanisms of Resilience and Neurodegeneration in Neurological Diseases and Healthy Aging
Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders
Recruiting
Subthalamic Nucleus Electrical Stimulation for Drug-resistant Focal Motor Epilepsy
Epilepsy, Drug Resistant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
Aatif Husain, MD principal investigator
Epilepsy Center of Excellence (ECoE) at the Durham VA Medical Center in Durham, North Carolina
Alan Towne, MD principal investigator
Epilepsy Center of Excellence (ECoE) at Hunter Holmes McGuire VA Medical Center in Richmond, Virginia
David Chen, MD principal investigator
Epilepsy Center of Excellence (ECoE) at the Michael E. DeBakey VA Medical Center in Houston, Texas
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 and video EEG in people with Epilepsy, Motor Partial and Psychogenic Seizures, 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 1 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 20 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?
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio. (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 20 Dec 2019.