Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples // Identification of Potential Biomarkers for Epilepsy in Human Sweat.

NCT04266990 | Terminated

• 1 other identifier: EC2019/1294
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

Dogs belonging to MDD will be trained and asked to discriminate between odour sweat samples from epilepsy patients associated with a seizure ("seizure sample") and samples collected when no seizure was close in time ("non-seizure sample"). The same type positive and negative sweat samples will be analysed by Florida International University using solid phase micro extraction (SPME) GC-MS to try to identify volatile organic components (VOC) specific to the samples associated with seizures.

Conditions

Epilepsy

Keywords

Epilepsy; Volatile Organic Components; Seizure detection; Medical detection dogs; Dog olfaction

Outcome Measures

Primary Outcomes (2)

• Answer to the question: Is possible to train Medical Detection Dogs to identify seizure-related samples using the sense of olfaction?

  Success rate of medical detection dogs when discriminating between seizure associated and non-seizure associated samples (success rate of 40% needed to be compared with a theoretical ratio of 14.3%)

  8 months

• VOC Identification

  Identification of volatile organic molecules (VOC) specific to seizure samples should they be present in human sweat

  8 months

Study Arms (2)

Epilepsy patients

EXPERIMENTAL

Epilepsy patients admitted for clinical purposes in the EEG monitoring units at the UZ

Other: Planned Sweat collection; Other: Spontaneous Sweat collection

Healthy volunteers

ACTIVE COMPARATOR

Healthy volunteers recruited from among colleagues from the department and hospital staff

Other: Healthy volunteers sweat collection

Interventions

Planned Sweat collection OTHER

Four times a day at fixed time points (9:30, 11:30, 13:30, 15:30), a researcher will ask the volunteers to wash their hands with non-scented soap and then place a sterile cotton gauze in the palm of their non-dominant hand. After 10 minutes, the gauze will be retrieved by the researcher.

Epilepsy patients

Spontaneous Sweat collection OTHER

As the patient will be under continuous monitoring, sweat and saliva samples will be also collected during and/or right after a seizure occurs if the volunteer is not holding a gauze at that time. The sweat samples will be collected by the researcher by applying a sterile gauze to the patients hands, either during or immediately following a seizure during 10 minutes.

Epilepsy patients

Healthy volunteers sweat collection OTHER

A researcher will ask the volunteers to wash their hands with non-scented soap and then place a sterile cotton gauze in the palm of their non-dominant hand. After 10 minutes, the gauze will be retrieved by the researcher. The healthy samples will be collected on the same floor of Ghent University Hospital and as close as possible to where patients reside

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The person will be an adult.
• The person will experience seizures implying both or either loss of conscience or incapability of interacting normally with the environment.
• Diagnostic of epilepsy confirmed by treating neurologist

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

UZ Gent

Ghent, Belgie, 9000, Belgium

Location

Related Publications (6)

• Brown SW, Goldstein LH. Can Seizure-Alert Dogs predict seizures? Epilepsy Res. 2011 Dec;97(3):236-42. doi: 10.1016/j.eplepsyres.2011.10.019. Epub 2011 Nov 1.

  PMID: 22050976 BACKGROUND

• Edney AT. Dogs and human epilepsy. Vet Rec. 1993 Apr 3;132(14):337-8. doi: 10.1136/vr.132.14.337. No abstract available.

  PMID: 8488638 BACKGROUND

• Rooney NJ, Morant S, Guest C. Investigation into the value of trained glycaemia alert dogs to clients with type I diabetes. PLoS One. 2013 Aug 7;8(8):e69921. doi: 10.1371/journal.pone.0069921. eCollection 2013.

  PMID: 23950905 BACKGROUND

• Wells DL, Lawson SW, Siriwardena AN. Canine responses to hypoglycemia in patients with type 1 diabetes. J Altern Complement Med. 2008 Dec;14(10):1235-41. doi: 10.1089/acm.2008.0288.

  PMID: 19040375 BACKGROUND

• Willis, C.M.., 2005. Olfactory detection of human bladder cancer by dogs: proof of principle study. Urologic Oncology: Seminars and Original Investigations, 23(3), p.217. Available at: http://linkinghub.elsevier.com/retrieve/pii/S1078143905000323.

  BACKGROUND

• Schmidt K, Podmore I. Current Challenges in Volatile Organic Compounds Analysis as Potential Biomarkers of Cancer. J Biomark. 2015;2015:981458. doi: 10.1155/2015/981458. Epub 2015 Mar 30.

  PMID: 26317039 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: February 12, 2020
• Study Start: January 20, 2020
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)