EpilepsyNCT03655366
Epidogs International Inventory of Seizure Alert Dogs
An observational study of Epilepsy, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This international research project looks at the reliability of canine seizure alerting behaviour in epilepsy patients. In the first stage an international database to identify the size and composition of the population of seizure alerting dogs has been created. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Questionnaire for Dog owners and Questionnaire for Dog trainers
- How many people
- 227 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2017to 1 Jul 2018
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Dog owners (adults and children) with epilepsy
Who may be able to join
- Adults ( >18 years) diagnosed with epilepsy who live with a dog
- Children (< 18 years) that have been diagnosed with epilepsy and live with a dog; represented by the parents
- Epilepsy patients with intellectual disabilities that live with a dog; represented by their legal representative
Who cannot join
- Participants or their representative must be able to answer questions using our online questionnaire. They must sign the inform consent to access the questionnaire.
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Department of Neurology - Ghent University Hospital
Ghent, Flanders, 9000
About this study
Official title: Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part 1:International Inventory of Seizure Dogs
This international research project looks at the reliability of canine seizure alerting behaviour in epilepsy patients. In the first stage an international database to identify the size and composition of the population of seizure alerting dogs has been created.
Read the detailed description
The size and composition of the population of seizure alerting dogs is still widely unknown, particularly the population of non-trained alerting dogs. Previously published studies have focused on anecdotal reports, single case studies, or small samples of the population. Some studies do not make a clear distinction between response and alert dogs and/or include only one type of alerting dogs. The objective of this study is to create an international alerting dog database including trained Seizure Alert Dogs (SADs), spontaneously alerting Seizure Response Dogs (SRDs) and spontaneously alerting pet dogs. This information will be used to select a representative sample of the population for subsequent work packages and to perform a descriptive analysis of the population of alerting dogs in and international context. For the database, two questionnaires will be developed: one will be directed to SDR and SAD trainers and a second one to epilepsy patients owning a dog.
Questionnaires
The Trainer Questionnaire will be sent to training organisations via email and will request the following information:
- Number of active working dogs.
- Dog demographic information and selection criteria.
- The type of patient inclusion criteria they use
- Training methods used.
- For SRD that spontaneously started anticipating seizures: information about further training that may have been provided.
The questionnaire directed to epilepsy patients owning dogs will be accessible from our website and will collect the following information:
- Demographic information
- Information about the seizures
- Type of dog: SAD or spontaneously alerting SRD or pet dog
- Approximate date when the dog started alerting, if it's an untrained dog.
- Demographic information about the dog.
- Type of alerting behaviour.
- Monash Canine Personality Questionnaire refined (MCPQ-R): Defines 5 traits of dog personalities.
- The Monash Dog-Owner Relationship Scale (MDORS) ) that studies the perceived bond between the patient and the dog. It consists of 28 items with a score ranging from 1 to 5 that characterizes the emotional closeness, the dog-owner interaction and the perceive costs of dog ownership (Only for patients older than 18 year old)
Recruitment
Collaboration with epilepsy research groups has been stablished inside and outside the EU (Belgium, UK, US, Italy< Germany and Spain).
A systematic online search was performed to identify all SRD and SAD training organisations across the world. These organisations were contacted via email and telephone (see email example document) and asked to participate in the study by completing the trainer questionnaire and by distributing information about the study and an invitation to participate between their clients.
To reach epileptic owners of non-trained dogs that presumably alert, the following organisations were contacted:
- Epilepsy support organizations.
- Medical non-profit organisations
- Social media groups and forums.
- neurology departments and epilepsy centers
Milestones
- To create an international database of alerting dogs (SAD and spontaneously alerting SRD and pet dogs) to be used in subsequent work packages.
- Descriptive analysis of the population of alerting dogs and their owners.
- A description of the human-dog relationship between epileptic patients and their dog (separated according to whether the dog is one that alerts or not). A description of "Personality traits" of alerting and non-alerting dogs.
- Conditions
- Epilepsy
- Being tested
- Questionnaire for Dog owners, Questionnaire for Dog trainers
- Keywords
- epilepsy, seizures, seizure alert dogs, seizure response dogs, assistance dogs
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire for Dog ownersOther
Questionnaire directed to epileptic patients, parents of epileptic children and legal representatives of epileptic patients with intellectual disabilities. It includes questions about demographics, epilepsy diagnosis, seizures, the behavior of their dogs around the time they have a seizure and a validates scale to measure dog personality traits.
Questionnaire for Dog trainersOther
Questionnaire for seizure response and seizure alert dog trainers including information on number of active working dogs, dog demographic information and selection criteria, the type of patient inclusion criteria they use, training methods used.
| Study group | Role | What they receive |
|---|---|---|
| Dog owners with epilepsy | Epilepsy patients that own one or more dogs. Receives: Other: Questionnaire for Dog owners | |
| Training organisations | Trainers of seizure response and seizure alerting dogs. Receives: Other: Questionnaire for Dog trainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive analysis of the population of owners of alerting and non-alerting dogs
Comparison of the responses from owners of alerting dogs and the responses of owners of non-alerting dogs in terms of type and frequency of seizures, presence or not od pre-ictal symptoms, etc.
Measured: Until October 2020
Secondary outcomes (2)
Differences in personality traits between alerting and non alerting dogs
Differences between the scores obtained in the MCPQ-R scale by alerting and non alerting dogs
Measured: Until October 2020
Differences in human-dog bond between alerting and non alerting dogs
Differences between the scores obtained in the MDORS scale by alerting and non alerting dogs
Measured: Until October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Sep 2017
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 227 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Christel Moons, PhD, Study director, Faculty of Veterinary Medicine, Ghent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655366
- Sponsor's protocol ID
- EC/2017/0934
- Status last verified
- Aug 2018
- First submitted
- 7 Nov 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dwyer, F., Bennett, P.C., Coleman, G.J., 2006. Development of the Monash Dog Owner Relationship Scale (MDORS). Anthrozoos 19, 243-256.
Kirton A, Wirrell E, Zhang J, Hamiwka L. Seizure-alerting and -response behaviors in dogs living with epileptic children. Neurology. 2004 Jun 22;62(12):2303-5. doi: 10.1212/wnl.62.12.2303.
PubMed 15210902Ley, J.M., Bennett, P.C., Coleman, G.J., 2009a. A refinement and validation of the Monash Canine Personality Questionnaire (MCPQ). Appl. Anim. Behav. Sci. 116, 220-227
Inter-rater and test-retest reliability of the Monash Canine Personality Questionnaire-Revised (MCPQ-R)
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. 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 1:International Inventory of Seizure Dogs
- ClinicalTrials.gov ID
- NCT03655366
- Acronym / sponsor ID
- EC/2017/0934
- Conditions
- Epilepsy
- Keywords
- epilepsy, seizures, seizure alert dogs, seizure response dogs, assistance dogs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 31 Aug 2018 (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.
This international research project looks at the reliability of canine seizure alerting behaviour in epilepsy patients. In the first stage an international database to identify the size and composition of the population of seizure alerting dogs has been created.
Detailed description
The size and composition of the population of seizure alerting dogs is still widely unknown, particularly the population of non-trained alerting dogs. Previously published studies have focused on anecdotal reports, single case studies, or small samples of the population. Some studies do not make a clear distinction between response and alert dogs and/or include only one type of alerting dogs. The objective of this study is to create an international alerting dog database including trained Seizure Alert Dogs (SADs), spontaneously alerting Seizure Response Dogs (SRDs) and spontaneously alerting pet dogs. This information will be used to select a representative sample of the population for subsequent work packages and to perform a descriptive analysis of the population of alerting dogs in and international context. For the database, two questionnaires will be developed: one will be directed to SDR and SAD trainers and a second one to epilepsy patients owning a dog.
Questionnaires
The Trainer Questionnaire will be sent to training organisations via email and will request the following information:
- Number of active working dogs.
- Dog demographic information and selection criteria.
- The type of patient inclusion criteria they use
- Training methods used.
- For SRD that spontaneously started anticipating seizures: information about further training that may have been provided.
The questionnaire directed to epilepsy patients owning dogs will be accessible from our website and will collect the following information:
- Demographic information
- Information about the seizures
- Type of dog: SAD or spontaneously alerting SRD or pet dog
- Approximate date when the dog started alerting, if it's an untrained dog.
- Demographic information about the dog.
- Type of alerting behaviour.
- Monash Canine Personality Questionnaire refined (MCPQ-R): Defines 5 traits of dog personalities.
- The Monash Dog-Owner Relationship Scale (MDORS) ) that studies the perceived bond between the patient and the dog. It consists of 28 items with a score ranging from 1 to 5 that characterizes the emotional closeness, the dog-owner interaction and the perceive costs of dog ownership (Only for patients older than 18 year old)
Recruitment
Collaboration with epilepsy research groups has been stablished inside and outside the EU (Belgium, UK, US, Italy< Germany and Spain).
A systematic online search was performed to identify all SRD and SAD training organisations across the world. These organisations were contacted via email and telephone (see email example document) and asked to participate in the study by completing the trainer questionnaire and by distributing information about the study and an invitation to participate between their clients.
To reach epileptic owners of non-trained dogs that presumably alert, the following organisations were contacted:
- Epilepsy support organizations.
- Medical non-profit organisations
- Social media groups and forums.
- neurology departments and epilepsy centers
Milestones
- To create an international database of alerting dogs (SAD and spontaneously alerting SRD and pet dogs) to be used in subsequent work packages.
- Descriptive analysis of the population of alerting dogs and their owners.
- A description of the human-dog relationship between epileptic patients and their dog (separated according to whether the dog is one that alerts or not). A description of "Personality traits" of alerting and non-alerting dogs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dog owners with epilepsy | – | Other: Questionnaire for Dog ownersEpilepsy patients that own one or more dogs. |
| Training organisations | – | Other: Questionnaire for Dog trainersTrainers of seizure response and seizure alerting dogs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dog owners (adults and children) with epilepsy
Key inclusion criteria (3 listed)
- Adults ( >18 years) diagnosed with epilepsy who live with a dog
- Children (< 18 years) that have been diagnosed with epilepsy and live with a dog; represented by the parents
- Epilepsy patients with intellectual disabilities that live with a dog; represented by their legal representative
Key exclusion criteria (1 listed)
- Participants or their representative must be able to answer questions using our online questionnaire. They must sign the inform consent to access the questionnaire.
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 |
|---|---|---|
| Questionnaire for Dog ownersQuestionnaire directed to epileptic patients, parents of epileptic children and legal representatives of epileptic patients with intellectual disabilities. It includes questions about demographics, epilepsy diagnosis, seizures, the behavior of their dogs around the time they have a seizure and a validates scale to measure dog personality traits. | Other | Dog owners with epilepsy |
| Questionnaire for Dog trainersQuestionnaire for seizure response and seizure alert dog trainers including information on number of active working dogs, dog demographic information and selection criteria, the type of patient inclusion criteria they use, training methods used. | Other | Training organisations |
Primary outcome
Descriptive analysis of the population of owners of alerting and non-alerting dogs
Time frame: Until October 2020
Comparison of the responses from owners of alerting dogs and the responses of owners of non-alerting dogs in terms of type and frequency of seizures, presence or not od pre-ictal symptoms, etc.
2 secondary outcomes
Differences in personality traits between alerting and non alerting dogs
Time frame: Until October 2020
Differences in human-dog bond between alerting and non alerting dogs
Time frame: Until October 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- BackgroundDwyer, F., Bennett, P.C., Coleman, G.J., 2006. Development of the Monash Dog Owner Relationship Scale (MDORS). Anthrozoos 19, 243-256.
- Background: PubMed 15210902Kirton A, Wirrell E, Zhang J, Hamiwka L. Seizure-alerting and -response behaviors in dogs living with epileptic children. Neurology. 2004 Jun 22;62(12):2303-5. doi: 10.1212/wnl.62.12.2303.
- BackgroundLey, J.M., Bennett, P.C., Coleman, G.J., 2009a. A refinement and validation of the Monash Canine Personality Questionnaire (MCPQ). Appl. Anim. Behav. Sci. 116, 220-227
- BackgroundInter-rater and test-retest reliability of the Monash Canine Personality Questionnaire-Revised (MCPQ-R)
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
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.
Christel Moons, PhD study director
Faculty of Veterinary Medicine, Ghent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 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: finished, as of the sponsor's last update on 31 Aug 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Descriptive analysis of the population of owners of alerting and non-alerting dogs (time frame: Until October 2020). 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 NCT03655366, which also lists 4 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 31 Aug 2018.