Epilepsy Motion Sensing

NCT ID: NCT01850498

Last Updated: 2013-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

19 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-04-30

Brief Summary

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Evaluate patient motion during seizures.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Partial seizures

Partial seizures with secondary generalization which results in visible clonic or tonic-clonic motor behavior

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedtronicNeuro

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mayo Clinic

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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1663

Identifier Type: -

Identifier Source: org_study_id

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