Recruitment

Recruitment Status
Completed

Inclusion Criteria

Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
18 years of age or older
Male or non-pregnant female
...
Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
18 years of age or older
Male or non-pregnant female
Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
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.
Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
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
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

Summary

Conditions
Epilepsy
Type
Observational
Design
  • Observational Model: Cohort
  • Time Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criteria

Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
18 years of age or older
Male or non-pregnant female
...
Determined by the Investigator to be an acceptable candidate for epilepsy evaluation with intracranial or scalp electrode monitoring
18 years of age or older
Male or non-pregnant female
Diagnosed with epilepsy and expected to have at least one motor seizure in the EMU
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.
Willing and able to wear 3 ActiGraph GT3X+ devices for the duration of their participation in the study and comply with the study protocol
Be able to consent to participate by signing the Informed Consent document after a full explanation of the nature and purpose of this study
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
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

Locations

Rochester, Minnesota, 55905
Rochester, Minnesota, 55905

Tracking Information

NCT #
NCT01850498
Collaborators
Not Provided
Investigators
Not Provided