Convulsion, Non-EpilepticNCT03013348
Automated Identification of Psychogenic Nonepileptic Seizures
An observational study of Convulsion, Non-Epileptic, run by Brain Sentinel.
Trial summary
A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures Read more about this study
- Who is it for?
- Ages 2 to 99 years
- Conditions the study is for
- Convulsion, Non-Epileptic
- What is being tested?
- Brain Sentinel's sEMG Post-processing algorithm
- Type of treatment
- Medical device
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Aug 2020
- Phase
- Observational
- 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 2 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES recorded during that admission.
Who may be able to join
- A subject will be eligible for inclusion in this study if the following criteria apply.
- Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission.
- Male or female between the ages of 2-99
- 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
Who cannot join
- No exclusion criteria have been established for this study.
About this study
A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures
Read the detailed description
This is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (sEMG) artifact previously recorded during routine video-electroencephalographic (vEEG) monitoring
- Conditions
- Convulsion, Non-Epileptic
- Being tested
- Brain Sentinel's sEMG Post-processing algorithm
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Sentinel's sEMG Post-processing algorithmDevice
Brain Sentinel has developed a post processing method that identifies sEMG signals (recorded from the biceps brachii or as muscle artifact in electroencephalography [EEG] recordings) that are pathognomonic for PNES activity.
| Study group | Role | What they receive |
|---|---|---|
| Adults (22-99), | Male or female subject between the ages of 22-99, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. Receives: Device: Brain Sentinel's sEMG Post-processing algorithm | |
| Adolescents (13-21) | Male or female subject between the ages of 13-21, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. Receives: Device: Brain Sentinel's sEMG Post-processing algorithm | |
| Children (2-12) | Male or female subject between the ages of 2-12, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. Receives: Device: Brain Sentinel's sEMG Post-processing algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
> 70% sensitivity of a post processing method for classification of psychogenic nonepileptic seizures in sEMG artifact captured during vEEG recordings as compared to vEEG interpretation by a panel of three independent Neurologists.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion21 May 2019
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Convulsion, Non-EpilepticStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Halford, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013348
- Sponsor's protocol ID
- NES-1.5-09.2016
- Status last verified
- Dec 2019
- First submitted
- 4 Jan 2017
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- 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
- Automated Identification of Psychogenic Nonepileptic Seizures
- ClinicalTrials.gov ID
- NCT03013348
- Acronym / sponsor ID
- NES-1.5-09.2016
- Conditions
- Convulsion, Non-Epileptic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- Aug 2020 (estimated)
- First posted
- 6 Jan 2017 (estimated)
- 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.
A retrospective validation study of a post-processing method intended to identify psychogenic nonepileptic seizures
Detailed description
This is a validation study of a post-processing method intended to identify psychogenic nonepileptic seizures by analysis of surface electromyographic (sEMG) artifact previously recorded during routine video-electroencephalographic (vEEG) monitoring
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults (22-99), | – | Device: Brain Sentinel's sEMG Post-processing algorithmMale or female subject between the ages of 22-99, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. |
| Adolescents (13-21) | – | Device: Brain Sentinel's sEMG Post-processing algorithmMale or female subject between the ages of 13-21, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. |
| Children (2-12) | – | Device: Brain Sentinel's sEMG Post-processing algorithmMale or female subject between the ages of 2-12, previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES was recorded during that admission. Validation of Brain Sentinel's sEMG Post-processing algorithm will involve prospective evaluation of at least 30 PNES events in this group. |
Who may qualify
- Ages
- 2 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit with at least one PNES recorded during that admission.
Key inclusion criteria (4 listed)
- A subject will be eligible for inclusion in this study if the following criteria apply.
- Subject was previously admitted to the Medical University of South Carolina for inpatient vEEG monitoring in the MUSC Epilepsy Monitoring Unit and at least one PNES was recorded during that admission.
- Male or female between the ages of 2-99
- 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)
- No exclusion criteria have been established for this study.
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 |
|---|---|---|
| Brain Sentinel's sEMG Post-processing algorithmBrain Sentinel has developed a post processing method that identifies sEMG signals (recorded from the biceps brachii or as muscle artifact in electroencephalography [EEG] recordings) that are pathognomonic for PNES activity. | Device | Adolescents (13-21), Adults (22-99),, Children (2-12) |
Primary outcome
> 70% sensitivity of a post processing method for classification of psychogenic nonepileptic seizures in sEMG artifact captured during vEEG recordings as compared to vEEG interpretation by a panel of three independent Neurologists.
Time frame: 6 months
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.
Jonathan Halford, MD principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
An observational study of Convulsion, Non-Epileptic, run by Brain Sentinel.
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 4 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
> 70% sensitivity of a post processing method for classification of psychogenic nonepileptic seizures in sEMG artifact captured during vEEG recordings as compared to vEEG interpretation by a panel of three independent Neurologists. (time frame: 6 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 19 Dec 2019.