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Completed

NCT Number: NCT03655366

Epidogs International Inventory of Seizure Alert 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology - Ghent University Hospital

Ghent, Flanders, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire for Dog owners

Other

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 trainers

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • University Ghent

Registry information

Official study title

Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part 1:International Inventory of Seizure Dogs

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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