Epilepsy Motion Sensing

NCT01850498 | Completed

• 1 other identifier: 1663
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate patient motion during seizures.

Conditions

Epilepsy

Keywords

Epilepsy; Seizure; Motor; Motion; Accelerometer

Outcome Measures

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).

  While patients are being evaluated in an epilepsy monitoring unit.

Secondary Outcomes (3)

• 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.

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with epilepsy referred to epilepsy monitoring unit.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: May 9, 2013
• Study Start: May 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 9, 2013

Record last verified: 2013-05

Locations

US (1)