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OpenTrials
Completed

NCT Number: NCT01850498

Epilepsy Motion Sensing

Evaluate patient motion during seizures.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

Motion Sensing Study in Epilepsy Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 2013
Registry last updated
May 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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