Non-Epileptic SeizureNCT03169751
An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
An observational study of Non-Epileptic Seizure and Motor Seizure, run by Brain Sentinel at 1 site in Austria.
Trial summary
This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Epileptic Seizure, Motor Seizure, Epilepsy
- What is being tested?
- Brain Sentinel Monitoring and Alerting System
- Type of treatment
- Medical device
- How many people
- 71 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2017to 1 Feb 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a suspected history of Psychogenic Non Epileptic Seizures with upper extremity motor involvement. and/or Epileptic Seizures with upper extremity motor involvement
Who may be able to join
- Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or female between the ages of 18-99.
- If female and of childbearing potential, has a negative pregnancy test.
- Can understand and sign written informed consent prior to the performance of any study assessments.
- Subject must be competent to follow all study procedures.
Who cannot join
- 1.Intracranial EEG electrodes are being used.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhugel
Vienna, 1130
About this study
This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.
- Conditions
- Non-Epileptic Seizure, Motor Seizure, Epilepsy
- Being tested
- Brain Sentinel Monitoring and Alerting System
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Sentinel Monitoring and Alerting SystemDevice
The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide 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 |
|---|---|---|
| PNES Cohort | Participants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial Receives: Device: Brain Sentinel Monitoring and Alerting System | |
| Epileptic Cohort | Participants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial Receives: Device: Brain Sentinel Monitoring and Alerting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG).
Measured: 5 days
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3)
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that > 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well.
Measured: 5 days
Secondary outcomes (1)
To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring
It is anticipated that >70% of GTC seizures identified by vEEG will be identified by the SPEAC System's automated alarms as well.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start1 Sep 2017
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Epileptic SeizureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brain Sentinel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christoph Baumgartner, MD, Principal investigator, Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169751
- Sponsor's protocol ID
- PNES-1.5-11.2016-EU
- Status last verified
- Dec 2019
- First submitted
- 20 Apr 2017
- Last updated
- 20 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
- ClinicalTrials.gov ID
- NCT03169751
- Acronym / sponsor ID
- PNES-1.5-11.2016-EU
- Conditions
- Non-Epileptic Seizure, Motor Seizure, Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Brain SentinelUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 30 May 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 an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNES Cohort | – | Device: Brain Sentinel Monitoring and Alerting SystemParticipants who experience a non-epileptic event with upper extremity motor involvement, while enrolled in the trial |
| Epileptic Cohort | – | Device: Brain Sentinel Monitoring and Alerting SystemParticipants who experience an epileptic event with upper extremity motor involvement, while enrolled in the trial |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a suspected history of Psychogenic Non Epileptic Seizures with upper extremity motor involvement. and/or Epileptic Seizures with upper extremity motor involvement
Key inclusion criteria (6 listed)
- Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement.
- Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- Male or female between the ages of 18-99.
- If female and of childbearing potential, has a negative pregnancy test.
- Can understand and sign written informed consent prior to the performance of any study assessments.
Key exclusion criteria (1 listed)
- 1.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 |
|---|---|---|
| Brain Sentinel Monitoring and Alerting SystemThe Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide 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 | Epileptic Cohort, PNES Cohort |
Primary outcome
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)
Time frame: 5 days
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG).
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3)
Time frame: 5 days
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that > 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well.
1 secondary outcome
To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring
Time frame: 5 days
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.
- Individual participant dataSharing planned: No
Related trials for Non-Epileptic Seizure
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
RecruitingEarly Phase 1
Accelerated TMS for Seizure-Type Functional Neurologic Disorders
Functional Neurological Symptom Disorder, Functional Seizures
Recruiting
Modulating Movement Intention Via Cortical Stimulation
Seizures, Seizure Disorder
Recruiting
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Epilepsy, Temporal Lobe, Drug Resistant Epilepsy
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.
Christoph Baumgartner, MD principal investigator
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Epileptic Seizure and Motor Seizure, run by Brain Sentinel at 1 site in Austria.
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 6 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 1 site in Austria. 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?
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3) (time frame: 5 days). The study lists 2 primary outcomes in all. 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.