EpilepsyNCT04266990
Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples // Identification of Potential Biomarkers for Epilepsy in Human Sweat.
A study testing Planned Sweat collection, Spontaneous Sweat collection and Healthy volunteers sweat collection in people with Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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"). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Planned Sweat collection, Spontaneous Sweat collection and Healthy volunteers sweat collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Jan 2020to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part III: Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples Part IV: Identification of Potential Biomarkers for Epilepsy in Human Sweat.
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.
Read the detailed description
For this research, three different types of samples will be collected
- seizure samples from patients: (S+)
- non-seizure samples from patients : (S-)
- samples from healthy people (H)
- positive control samples consisting of a standard chemical mix (C+) (Only for part IV)
- negative control samples with gauze exposed to the environment in which the samples from patients and healthy people are taken). (C-) (Only for part IV)
2.1 Collection of type a and b samples (from patients)
Sweat samples will be collected from epilepsy patients admitted for clinical purposes in the 4 EEG units at the UZ. At the time of admission, they will be asked if they agree to collaborate with the study and with their samples being taken. The patients' care is the responsibility of the staff of Ghent University Hospital. The researcher from this study will be present to collect samples in consultation with the nursing staff.
Sample collection
All the collection material will be treated with HPLC-grade methanol, and then heated to 110 degrees in an oven. The treated material will be kept in 40 ml glass vials until the collection time.
- Planned samples:
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. They will be asked to close the fist and keep the gauze for 10 minutes. After 10 minutes, the gauze will be retrieved by the researcher. After later analyzing the EEG readings, the samples will be marked as S+ if a seizure happened during those 10 minutes, or S- if no seizure occurred. Samples collected 24 hours before and after a seizure will not be used for further analysis.
- Spontaneous samples
As the patient will be under continuous monitoring, sweat 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. The samples will be marked as S+ after confirming with the EEG reading.
2.2 Collection of type c samples (from healthy people)
In order to ensure that environmental odour is not a confounder, samples will be also collected from healthy volunteers in the same location as where samples from patients are collected. Only sweat samples will be collected from healthy volunteers.These samples are identified as healthy samples (H). Attempts to match the samples from healthy people with those from patients based age, gender and ethnicity will be made.The healthy volunteers will be recruited from among colleagues from the department and UZ staff.
The healthy samples will be collected on the same floor of Ghent University Hospital and as close as possible to where patients reside.
2.3 Sample processing.
The gauzes containing the sweat samples will be cut in 4 pieces. Two pieces will be stored in glass vials, one frozen to -20 °C and the other stored at room temperature, these samples will be sent to shipped to Florida International University. The remaining two pieces, will be shipped to Medical Detection Dogs, will be stored in sterile Falcon tubes and frozen at -20 °C.
2.4 Medical Detection Dogs sample analysis
Two dogs belonging to MDD will be asked to discriminate between seizure and non-seizure samples from patients. They will also be asked to discriminate between seizure-samples, non-seizure samples and healthy samples. The dogs will be using an 8-arms carousel. Seven samples will be placed in one arm each and one arm will remain empty.
First, dogs must be trained to recognize the hypothetical odour that is associated with epilepsy. Consequently, prior to the trial, 30 seizure samples from different patients and 120 non-seizure and healthy samples are needed for the training of the dogs
Next, 24 seizure samples from different patients and 144 non-seizure and healthy samples will be used in a double-blinded trial (24 panels with 1 seizure samples and 6 non-seizure or healthy samples). Sample size calculation is based on the assumption of a success rate of 40% to be compared with a theoretical ratio of 14.3%. A power analysis indicates that a sample size of 24 test panels is large enough to reach a power of 80% with an alpha level of 0.05 (two-sided).
2.5. Chemical analysis
Seizure samples, non-seizure samples, healthy samples and the positive and negative controls will be sent to Florida International University for SPME GC-MS analysis.
Every month for as long as the study lasts, 3 S+, 15 S-, 5 H, 1 C+ and 1 C- sample will be shipped. Analysis of the VOC profile will allow to identify potential molecules specific to the samples associated with seizures.
- Conditions
- Epilepsy
- Being tested
- Planned Sweat collection, Spontaneous Sweat collection, Healthy volunteers sweat collection
- Keywords
- Epilepsy, Volatile Organic Components, Seizure detection, Medical detection dogs, Dog olfaction
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned Sweat collectionOther
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.
Spontaneous Sweat collectionOther
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.
Healthy volunteers sweat collectionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy patients | Experimental | Epilepsy patients admitted for clinical purposes in the EEG monitoring units at the UZ Receives: Other: Planned Sweat collection; Other: Spontaneous Sweat collection |
| Healthy volunteers | Active comparator | Healthy volunteers recruited from among colleagues from the department and hospital staff Receives: Other: Healthy volunteers sweat collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%)
Measured: 8 months
VOC Identification
Identification of volatile organic molecules (VOC) specific to seizure samples should they be present in human sweat
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start20 Jan 2020
- Primary completion13 Mar 2020
- Study completion13 Mar 2020
Why it stopped: COVID-10 outbreak forced us to cancel the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266990
- Sponsor's protocol ID
- EC2019/1294
- Status last verified
- Jan 2023
- First submitted
- 21 Jan 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22050976Edney AT. Dogs and human epilepsy. Vet Rec. 1993 Apr 3;132(14):337-8. doi: 10.1136/vr.132.14.337. No abstract available.
PubMed 8488638Rooney 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.
PubMed 23950905Wells 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.
PubMed 19040375Willis, 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.
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.
PubMed 26317039
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part III: Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples Part IV: Identification of Potential Biomarkers for Epilepsy in Human Sweat.
- ClinicalTrials.gov ID
- NCT04266990
- Acronym / sponsor ID
- EC2019/1294
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Volatile Organic Components, Seizure detection, Medical detection dogs, Dog olfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-10 outbreak forced us to cancel the study
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 13 Mar 2020 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 12 Feb 2020 (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.
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.
Detailed description
For this research, three different types of samples will be collected
- seizure samples from patients: (S+)
- non-seizure samples from patients : (S-)
- samples from healthy people (H)
- positive control samples consisting of a standard chemical mix (C+) (Only for part IV)
- negative control samples with gauze exposed to the environment in which the samples from patients and healthy people are taken). (C-) (Only for part IV)
2.1 Collection of type a and b samples (from patients)
Sweat samples will be collected from epilepsy patients admitted for clinical purposes in the 4 EEG units at the UZ. At the time of admission, they will be asked if they agree to collaborate with the study and with their samples being taken. The patients' care is the responsibility of the staff of Ghent University Hospital. The researcher from this study will be present to collect samples in consultation with the nursing staff.
Sample collection
All the collection material will be treated with HPLC-grade methanol, and then heated to 110 degrees in an oven. The treated material will be kept in 40 ml glass vials until the collection time.
- Planned samples:
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. They will be asked to close the fist and keep the gauze for 10 minutes. After 10 minutes, the gauze will be retrieved by the researcher. After later analyzing the EEG readings, the samples will be marked as S+ if a seizure happened during those 10 minutes, or S- if no seizure occurred. Samples collected 24 hours before and after a seizure will not be used for further analysis.
- Spontaneous samples
As the patient will be under continuous monitoring, sweat 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. The samples will be marked as S+ after confirming with the EEG reading.
2.2 Collection of type c samples (from healthy people)
In order to ensure that environmental odour is not a confounder, samples will be also collected from healthy volunteers in the same location as where samples from patients are collected. Only sweat samples will be collected from healthy volunteers.These samples are identified as healthy samples (H). Attempts to match the samples from healthy people with those from patients based age, gender and ethnicity will be made.The healthy volunteers will be recruited from among colleagues from the department and UZ staff.
The healthy samples will be collected on the same floor of Ghent University Hospital and as close as possible to where patients reside.
2.3 Sample processing.
The gauzes containing the sweat samples will be cut in 4 pieces. Two pieces will be stored in glass vials, one frozen to -20 °C and the other stored at room temperature, these samples will be sent to shipped to Florida International University. The remaining two pieces, will be shipped to Medical Detection Dogs, will be stored in sterile Falcon tubes and frozen at -20 °C.
2.4 Medical Detection Dogs sample analysis
Two dogs belonging to MDD will be asked to discriminate between seizure and non-seizure samples from patients. They will also be asked to discriminate between seizure-samples, non-seizure samples and healthy samples. The dogs will be using an 8-arms carousel. Seven samples will be placed in one arm each and one arm will remain empty.
First, dogs must be trained to recognize the hypothetical odour that is associated with epilepsy. Consequently, prior to the trial, 30 seizure samples from different patients and 120 non-seizure and healthy samples are needed for the training of the dogs
Next, 24 seizure samples from different patients and 144 non-seizure and healthy samples will be used in a double-blinded trial (24 panels with 1 seizure samples and 6 non-seizure or healthy samples). Sample size calculation is based on the assumption of a success rate of 40% to be compared with a theoretical ratio of 14.3%. A power analysis indicates that a sample size of 24 test panels is large enough to reach a power of 80% with an alpha level of 0.05 (two-sided).
2.5. Chemical analysis
Seizure samples, non-seizure samples, healthy samples and the positive and negative controls will be sent to Florida International University for SPME GC-MS analysis.
Every month for as long as the study lasts, 3 S+, 15 S-, 5 H, 1 C+ and 1 C- sample will be shipped. Analysis of the VOC profile will allow to identify potential molecules specific to the samples associated with seizures.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy patients | Experimental | Other: Planned Sweat collection, Other: Spontaneous Sweat collectionEpilepsy patients admitted for clinical purposes in the EEG monitoring units at the UZ |
| Healthy volunteers | Active comparator | Other: Healthy volunteers sweat collectionHealthy volunteers recruited from among colleagues from the department and hospital staff |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Planned Sweat collectionFour 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. | Other | Epilepsy patients |
| Spontaneous Sweat collectionAs 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. | Other | Epilepsy patients |
| Healthy volunteers sweat collectionA 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 | Other | Healthy volunteers |
Primary outcome
Answer to the question: Is possible to train Medical Detection Dogs to identify seizure-related samples using the sense of olfaction?
Time frame: 8 months
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%)
VOC Identification
Time frame: 8 months
Identification of volatile organic molecules (VOC) specific to seizure samples should they be present in human sweat
Results and safety
The study was stopped early (reason given: COVID-10 outbreak forced us to cancel the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 22050976Brown 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.
- Background: PubMed 8488638Edney AT. Dogs and human epilepsy. Vet Rec. 1993 Apr 3;132(14):337-8. doi: 10.1136/vr.132.14.337. No abstract available.
- Background: PubMed 23950905Rooney 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.
- Background: PubMed 19040375Wells 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.
- BackgroundWillis, 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: PubMed 26317039Schmidt 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned Sweat collection, Spontaneous Sweat collection and Healthy volunteers sweat collection in people with Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
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 3 inclusion and 0 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: stopped early, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
The study was stopped early (reason given: COVID-10 outbreak forced us to cancel the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Answer to the question: Is possible to train Medical Detection Dogs to identify seizure-related samples using the sense of olfaction? (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266990, which also lists 6 linked publications.
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 4 Jan 2023.