Epidogs International Inventory of Seizure Alert Dogs

August 30, 2018 updated by: University Hospital, Ghent

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.

Study Overview

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 Type

Observational

Enrollment (Actual)

227

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Flandes
      • Ghent, Flandes, Belgium, 9000
        • Department of Neurology - Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dog owners (adults and children) with epilepsy

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Participants or their representative must be able to answer questions using our online questionnaire. They must sign the inform consent to access the questionnaire.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dog owners with epilepsy
Epilepsy patients that own one or more dogs.
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.
Training organisations
Trainers of seizure response and seizure alerting dogs.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until October 2020

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in personality traits between alerting and non alerting dogs
Time Frame: Until October 2020
Differences between the scores obtained in the MCPQ-R scale by alerting and non alerting dogs
Until October 2020
Differences in human-dog bond between alerting and non alerting dogs
Time Frame: Until October 2020
Differences between the scores obtained in the MDORS scale by alerting and non alerting dogs
Until October 2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Christel Moons, PhD, Faculty of Veterinary Medicine, Ghent University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 7, 2017

First Submitted That Met QC Criteria

August 30, 2018

First Posted (Actual)

August 31, 2018

Study Record Updates

Last Update Posted (Actual)

August 31, 2018

Last Update Submitted That Met QC Criteria

August 30, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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