Epilepsy Motion Sensing

Epilepsy Clinical Trial

Official title:

Motion Sensing Study in Epilepsy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01850498
• Other study ID #: 1663
• Status: Completed
• Phase: N/A
• First received: November 1, 2012
• Last updated: May 6, 2013
• Start date: May 2012
• Est. completion date: April 2013

Study information

• Verified date: May 2013
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Evaluate patient motion during seizures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Evaluate the accuracy of an accelerometer in identifying seizures (compared to EEG readings).		While patients are being evaluated in an epilepsy monitoring unit.	No
Secondary	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.	No
Secondary	Evaluate heart rate and rhythm changes associated with seizure onset (compared to ECG readings).		While patients are being evaluated in an epilepsy monitoring unit.	No