VIBES: Volatile Non-Invasive Biomarkers of Epileptic Seizures

• Sponsor: University College London Hospitals (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05725174
• Collaborator: Imperial College London (Other)
• Enrollment: 270
• Locations: 2
• Anticipated Duration (Months): 36.1
• Patients Per Site: 135
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

The plan of this study will be to collect breath samples and sebum swabs before and at different times after an epileptic seizure or a non-epileptic attack.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Non-Epileptic Seizure	Other: Sample Collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 270 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Volatile Non-Invasive Biomarkers of Epileptic Seizures
• Actual Study Start Date: Jan 30, 2023
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Feb 1, 2026

Outcome Measures

Primary Outcome Measures

1. Distinguishing epileptic from non-epileptic seizures [3 years]

   To distinguish epileptic from non-epileptic seizures with the detection of volatile organic compounds (VOCs) in breath and sebum samples.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chalfont Centre for Epilepsy	London	Buckinghamshire	United Kingdom	SL9 0RJ
2	National Hospital for Neurology and Neurosurgery	London		United Kingdom	WC1N 3BG

Sponsors and Collaborators

• University College London Hospitals
• Imperial College London

Investigators

• Principal Investigator: Matthew Walker, MB BChir FRCP, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eleonora Lugara, Dr, University College London Hospitals
• ClinicalTrials.gov Identifier: NCT05725174
• Other Study ID Numbers: 285913; 22/LO/0808
• First Posted: Feb 13, 2023
• Last Update Posted: Feb 13, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy; Seizures

Study Results

No Results Posted as of Feb 13, 2023