EpilepsyVIBESNCT05725174
Volatile Non-Invasive Biomarkers of Epileptic Seizures
An observational study of Epilepsy and Non-Epileptic Seizure, run by University College London Hospitals at 2 sites in United Kingdom.
Trial summary
Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Non-Epileptic Seizure
- What is being tested?
- Sample Collection
- How many people
- 270 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 30 Jan 2023to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with a diagnosis of epileptic or non-epileptic seizures
Who may be able to join
- Patients who have been admitted to either University College London's Queen's Square EEG-telemetry unit or Chalfont Centre for Epilepsy, for diagnosis of seizure events.
- Patients aged 18 years or above
Who cannot join
- Patients with active infection or who have taken antibiotics within 4 weeks
- Patients on immunosuppressive medications
- Patients with co-morbidities preventing breath collection
- Patients unable to provide informed consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Grace Luff, MSc contact
United Kingdom2 sites, 2 recruiting
- Recruiting
Chalfont Centre for Epilepsy
London, Buckinghamshire, SL9 0RJ
Grace Luff, MSc, 07443415438, g.luff@ucl.ac.uk
- Recruiting
National Hospital for Neurology and Neurosurgery
London, London, WC1N 3BG
Grace Luff, MSc, 07443415438
Matthew Walker, MB BChir FRCP
About this study
Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.
Read the detailed description
Determining whether someone has had an epileptic seizure, or another event, can be challenging and result in the wrong diagnosis. A 'seizure test' used after the event would therefore be very helpful.
Researchers have used small molecules released from the body in breath and sweat to detect cancers and other diseases; this study will determine whether a similar method can be used to detect whether someone has had an epileptic seizure.
- Conditions
- Epilepsy, Non-Epileptic Seizure
- Being tested
- Sample Collection
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample CollectionOther
Patients will have breath samples collected by blowing into a bag, and sweat samples collected by gauze. These samples will be collected at various timepoints whilst the patients are admitted on the ward.
What is being measured
The primary outcome is the main question the study is designed to answer.
Distinguishing epileptic from non-epileptic seizures
To distinguish epileptic from non-epileptic seizures with the detection of volatile organic compounds (VOCs) in breath and sebum samples.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start30 Jan 2023
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Principal investigator, Eleonora Lugara, University College London Hospitals
- Investigators
- Matthew Walker, MB BChir FRCP, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725174
- Sponsor's protocol ID
- 285913
- Other IDs
- 22/LO/0808
- Acronym
- VIBES
- Status last verified
- Dec 2024
- First submitted
- 2 Feb 2023
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If necessary, anonymised data will be shared with other researchers in a case by case scenario. For anonymised data to be shared with commercial entities, a research contract will need to be evaluated.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatile Non-Invasive Biomarkers of Epileptic Seizures
- ClinicalTrials.gov ID
- NCT05725174
- Acronym / sponsor ID
- VIBES / 285913
- Conditions
- Epilepsy, Non-Epileptic Seizure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 13 Feb 2023 (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.
Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.
Detailed description
Determining whether someone has had an epileptic seizure, or another event, can be challenging and result in the wrong diagnosis. A 'seizure test' used after the event would therefore be very helpful.
Researchers have used small molecules released from the body in breath and sweat to detect cancers and other diseases; this study will determine whether a similar method can be used to detect whether someone has had an epileptic seizure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with a diagnosis of epileptic or non-epileptic seizures
Key inclusion criteria (2 listed)
- Patients who have been admitted to either University College London's Queen's Square EEG-telemetry unit or Chalfont Centre for Epilepsy, for diagnosis of seizure events.
- Patients aged 18 years or above
Key exclusion criteria (4 listed)
- Patients with active infection or who have taken antibiotics within 4 weeks
- Patients on immunosuppressive medications
- Patients with co-morbidities preventing breath collection
- Patients unable to provide informed consent.
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 |
|---|---|---|
| Sample CollectionPatients will have breath samples collected by blowing into a bag, and sweat samples collected by gauze. These samples will be collected at various timepoints whilst the patients are admitted on the ward. | Other | – |
Primary outcome
Distinguishing epileptic from non-epileptic seizures
Time frame: 3 years
To distinguish epileptic from non-epileptic seizures with the detection of volatile organic compounds (VOCs) in breath and sebum samples.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: Undecided. If necessary, anonymised data will be shared with other researchers in a case by case scenario. For anonymised data to be shared with commercial entities, a research contract will need to be evaluated.
Related trials for Epilepsy
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Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, 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.
Grace Luff, MSc contact
Matthew Walker, MB BChir FRCP principal investigator
Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Non-Epileptic Seizure, run by University College London Hospitals at 2 sites in United Kingdom.
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 2 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: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eleonora Lugara, PhD (02031089108, e.lugara@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distinguishing epileptic from non-epileptic seizures (time frame: 3 years). 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 6 Dec 2024.