Volatile Non-Invasive Biomarkers of Epileptic Seizures

Epilepsy Clinical Trial

— VIBES  

Official title:

Volatile Non-Invasive Biomarkers of Epileptic Seizures

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05725174
• Other study ID #: 285913
• Secondary ID: 22/LO/0808
• Status: Recruiting
• Start date: January 30, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: August 2023
• Source: University College London Hospitals
• Contact: Eleonora Lugara, PhD
• Phone: 02031089108
• Email: e.lugara[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Patients aged 18 years or above

Exclusion Criteria:

1. Patients with active infection or who have taken antibiotics within 4 weeks

2. Patients on immunosuppressive medications

3. Patients with co-morbidities preventing breath collection

4. Patients unable to provide informed consent.

Related Conditions & MeSH terms

• Epilepsy
• Non-Epileptic Seizure
• Seizures

Intervention

Other:
• Sample Collection
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.

Locations

Country	Name	City	State
United Kingdom	Chalfont Centre for Epilepsy	London	Buckinghamshire
United Kingdom	National Hospital for Neurology and Neurosurgery	London

Sponsors (2)

Lead Sponsor	Collaborator
University College London Hospitals	Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years