Epilepsy Motion Sensing

Completed

• Conditions: Epilepsy

• Registration Number: NCT01850498
• Lead Sponsor: MedtronicNeuro

Brief Summary

Evaluate patient motion during seizures.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-11-01
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2013-05
• Study First Submitted QC: 2013-05-06
• Last Update Submitted: 2013-05-06
• Study First Posted: 2013-05-09
• Last Update Posted: 2013-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States