Volatile Non-Invasive Biomarkers of Epileptic Seizures (VIBES)

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Non-Epileptic Seizure
• Intervention / Treatment: Other: Sample Collection

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 Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Eleonora Lugara, PhD; Phone Number: 02031089108; Email: e.lugara@ucl.ac.uk
• Study Contact Backup: Name: Grace Luff, MSc; Email: g.luff@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, WC1N 3BG
    • Recruiting
    • National Hospital For Neurology and Neurosurgery
    • Contact: Grace Luff, MSc; Phone Number: 07443415438
    • Contact: Matthew Walker, MB BChir FRCP
  • Buckinghamshire
    • London, Buckinghamshire, United Kingdom, SL9 0RJ
      • Recruiting
      • Chalfont Centre for Epilepsy
      • Contact: Grace Luff, MSc; Phone Number: 07443415438; Email: g.luff@ucl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People with a diagnosis of epileptic or non-epileptic seizures

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Collaborators: Imperial College London
• Investigators: Principal Investigator: Matthew Walker, MB BChir FRCP, Professor

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Seizures
• Other Study ID Numbers: 285913; 22/LO/0808 (Other Identifier: REC Reference)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No