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EPIDOGS Digital Seizure Diary for Owners of Alerting Dogs

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ClinicalTrials.gov Identifier: NCT03896386
Recruitment Status : Not yet recruiting
First Posted : April 1, 2019
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
During a three-month period, the study subjects will be using an electronic diary app that they can download and install on their smartphones to register the occurrence of seizures and also to register the potential alerting behaviour of their dogs. This information will increase the knowledge of the accuracy of these alerts.

Condition or disease Intervention/treatment Phase
Epilepsy Other: Use of seizure diary Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms: EPIDOGS Digital Seizure Diary
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Use of seizure diary
People diagnosed with epilepsy that lives with a dog that is able to anticipate the onset of a seizure. They will be ask to use a diary (bespoke smartphone app) to register the occurrence of seizures and the alerting behaviour of the dogs.
Other: Use of seizure diary
The participants will press the "alert" button when they witness and alerting behaviour on their dogs or the "Seizure" button when they had experienced a seizure. We will receive this information live through the app back-end




Primary Outcome Measures :
  1. Sensitivity and specificity across all dogs. [ Time Frame: 3 months ]
    Percentage of dog alerts followed by a seizure, percentage of seizures preceded by a dog alert


Secondary Outcome Measures :
  1. Differences between trained and untrained dogs [ Time Frame: 3 months ]
    Information on potential differences in in the type of alerting behaviour displayed, sensitivity and specificity between trained and not trained dogs (if enough data are available).

  2. Correlation between alerting behaviour and pre-ictal symptoms [ Time Frame: 3 months ]
    A possible correlation between alerting behaviour and the presence of auras and/or prodromi may also be explored.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The volunteer has been diagnosed with epilepsy by a neurologist and lives with a dog that anticipates the occurrence of seizures (trained or not)
  • Volunteers should be able to operate an electronic diary app on a smartphone by themselves or will have an assistant/carer with them 24/24 that will operate the device for them.
  • In the case of children, the parents/tutors will fill in the diary for them.
  • In the case of people with learning disabilities, carers or familiars will fill in the diary for them.

Exclusion Criteria:

- People with non-epileptic seizures, that are not able to use a smartphone's app or that can't provide us with a confirmation of their diagnosis.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896386


Contacts
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Contact: Ana M Martos Martinez-Caja, MSc +3292647818 ana.martos@ugent.be
Contact: Veerle De Herdt, MD, PhD +32 (0) 93324529 Veerle.DeHerdt@ugent.be

Locations
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Belgium
Department of Neurology - Ghent University Hospital Not yet recruiting
Ghent, Flandes, Belgium, 9000
Contact: Veerle De Herdt, MD, PhD    +32-9-3324529    Veerle.DeHerdt@ugent.be   
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Investigators
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Study Director: Christel Moons, PhD Faculty of Veterinary Medicine, Ghent

Publications:
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03896386     History of Changes
Other Study ID Numbers: EC/2018/0232
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Ghent:
Epilepsy
Seizures
Seizure alert dogs
Seizure diary
Additional relevant MeSH terms:
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Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents