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Epilepsy Motion Sensing

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ClinicalTrials.gov Identifier: NCT01850498
Recruitment Status : Completed
First Posted : May 9, 2013
Last Update Posted : May 9, 2013
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief Summary:
Evaluate patient motion during seizures.

Condition or disease
Epilepsy

Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Motion Sensing Study in Epilepsy Patients
Study Start Date : May 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Group/Cohort
Partial seizures
Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior
Generalized seizures
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.



Primary Outcome Measures :
  1. 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). [ Time Frame: While patients are being evaluated in an epilepsy monitoring unit. ]

Secondary Outcome Measures :
  1. Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings). [ Time Frame: While patients are being evaluated in an epilepsy monitoring unit. ]
  2. Evaluate whether certain seizure types are more capable of being identified by the accelerometer (compared to EEG readings). [ Time Frame: While patients are being evaluated in an epilepsy monitoring unit. ]
  3. Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings). [ Time Frame: While patients are being evaluated in an epilepsy monitoring unit. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with epilepsy referred to epilepsy monitoring unit.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850498


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
MedtronicNeuro

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01850498     History of Changes
Other Study ID Numbers: 1663
First Posted: May 9, 2013    Key Record Dates
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by MedtronicNeuro:
Epilepsy
Seizure
Motor
Motion
Accelerometer

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases