Epilepsy Motion Sensing

Study Overview
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Brief Summary
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Evaluate patient motion during seizures.

Official Title
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Motion Sensing Study in Epilepsy Patients

Conditions
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Epilepsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol Have one of the following seizure types: (a) partial seizures with secondary generalization, which results in visible clonic or tonic-clonic motor behavior; (b) primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures. Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study Male or non-pregnant female English speaking Exclusion Criteria: Currently enrolled in another investigational device, drug, or surgery study. Concurrent physiologic study participation is acceptable Have an implanted device that may interfere with GT3X+ recordings, ECoG/EEG recordings, ECG recordings, or video recordings Have a movement disorder that may affect GT3X+ recordings

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Partial seizures<br>Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior | |
| Generalized seizures<br>Primarily generalized seizures (in patients with either primary [idiopathic] or secondary [symptomatic] generalized epilepsy), which may involve the following depending on the motor manifestation observed: myoclonic seizures, clonic seizures, tonic-clonic seizures, or atonic seizures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify and evaluate seizure characteristics derived from an accelerometer that can be used in development of a seizure detection algorithm (compared to EEG readings). |  | While patients are being evaluated in an epilepsy monitoring unit. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings). |  | While patients are being evaluated in an epilepsy monitoring unit. | 
| Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings). |  | While patients are being evaluated in an epilepsy monitoring unit. | 
| Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings). |  | While patients are being evaluated in an epilepsy monitoring unit. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Seizure, Motor, Motion, Accelerometer