Ignite Creation Date:
2024-05-06 @ 2:16 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04266990
Status:
TERMINATED
Last Update Posted:
2023-01-04
First Post:
2020-01-21
Brief Title:
Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples Identification of Potential Biomarkers for Epilepsy in Human Sweat
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
COVID-10 outbreak forced us to cancel the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
1 seizure samples from patients S
2 non-seizure samples from patients S-
3 samples from healthy people H
4 positive control samples consisting of a standard chemical mix C Only for part IV
5 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
21 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
A Planned samples
Four times a day at fixed time points 930 1130 1330 1530 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
B Spontaneous samples
As the patient will be under continuous monitoring sweat samples will be also collected during andor 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
22 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 volunteersThese 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 madeThe 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
23 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
24 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 143 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 005 two-sided
25 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
1 seizure samples from patients S
2 non-seizure samples from patients S-
3 samples from healthy people H
4 positive control samples consisting of a standard chemical mix C Only for part IV
5 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
21 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
A Planned samples
Four times a day at fixed time points 930 1130 1330 1530 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
B Spontaneous samples
As the patient will be under continuous monitoring sweat samples will be also collected during andor 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
22 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 volunteersThese 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 madeThe 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
23 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
24 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 143 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 005 two-sided
25 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None