TerminatedInterventionalNot ApplicableUpdated Nov 23, 2010
Epilepsy Motion Sensing | NCT01850498 | Trialant
CompletedObservationalUpdated May 9, 2013
Epilepsy Motion Sensing
Motion Sensing Study in Epilepsy Patients
ClinicalTrials.gov ID
NCT01850498
Lead Sponsor
MedtronicNeuroINDUSTRY
Overall Status
Completed
Study Type
Observational
Enrollment
19Actual
Last Update Posted
May 9, 2013Estimated
Start Date
May 2012
Primary Completion Date
Apr 2013Actual
Completion Date
Apr 2013Actual
Official Title
Motion Sensing Study in Epilepsy Patients
Brief Summary
Evaluate patient motion during seizures.
Epilepsy
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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