Epilepsy Motion Sensing

Motion Sensing Study in Epilepsy Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01850498

Enrollment

Registered

2013-05-09

Start date

2012-05-31

Completion date

2013-04-30

Last updated

2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

Epilepsy, Seizure, Motor, Motion, Accelerometer

Brief summary

Evaluate patient motion during seizures.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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.

Countries

United States

Outcome results