NCT01486056

Brief Summary

This is a prospective, unblinded, non-randomized, descriptive study designed to collect ECG data.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

November 28, 2011

Last Update Submit

August 20, 2012

Conditions

Epilepsy

Keywords

epilepsyECGdevice placement

Outcome Measures

Primary Outcomes (1)

  • To correlate ECG amplitude with prospective VNS implant sites.

    This study is designed to collect ECG data to determine the process for proper generator and lead placement.

    up to 2 days

Secondary Outcomes (1)

  • To identify potential VNS implant sites associated with low ECG amplitudes.

    up to 2 days

Study Arms (1)

healthy patients, may have epilepsy

Subjects at least 12 years old and in general good health for Phase I, and at least 18 years old and in general good health for Phase II. It is desired, but not required, for subjects to have epilepsy and taking at least 1 antiepileptic medication.

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects 12 years and older in general good health, preferably with epilepsy and on at least 1 antiepileptic medication.

You may qualify if:

  • At least 12 years old and in general good health for Phase I. At least 18 years old and in general good health for Phase II.
  • Patients or their guardians must be willing to provide signed informed consent/assent and HIPAA authorization. Note: Patients diagnosed with epilepsy and taking at least 1 antiepileptic medication are desired but not required for the study.

You may not qualify if:

  • History of pathologically significant cardiac arrhythmias including but not limited to atrial fibrillation or flutter, chronotropic incompetence, supraventricular tachycardia, ventricular flutter or fibrillation, or implantation of a permanent cardiac pacemaker or defibrillator.
  • Currently present existing signs of skin irritation or rash on the left neck or upper left chest as determined by the PI.
  • History of physical adverse reaction to adhesive electrodes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (8)

  • VAN BUREN JM. Some autonomic concomitants of ictal automatism; a study of temporal lobe attacks. Brain. 1958 Dec;81(4):505-28. doi: 10.1093/brain/81.4.505. No abstract available.

    PMID: 13618449BACKGROUND

  • Marshall DW, Westmoreland BF, Sharbrough FW. Ictal tachycardia during temporal lobe seizures. Mayo Clin Proc. 1983 Jul;58(7):443-6.

    PMID: 6865478BACKGROUND

  • Keilson MJ, Hauser WA, Magrill JP. Electrocardiographic changes during electrographic seizures. Arch Neurol. 1989 Nov;46(11):1169-70. doi: 10.1001/archneur.1989.00520470023018.

    PMID: 2818251BACKGROUND

  • Smith PE, Howell SJ, Owen L, Blumhardt LD. Profiles of instant heart rate during partial seizures. Electroencephalogr Clin Neurophysiol. 1989 Mar;72(3):207-17. doi: 10.1016/0013-4694(89)90245-9.

    PMID: 2465123BACKGROUND

  • O'Donovan C, Burgess R, Luders H., Computerized seizure detection based on heart rate changes. Epilepsia 1995;36(suppl 4):7.

    BACKGROUND

  • Schernthaner C, Lindinger G, Potzelberger K, Zeiler K, Baumgartner C. Autonomic epilepsy--the influence of epileptic discharges on heart rate and rhythm. Wien Klin Wochenschr. 1999 May 21;111(10):392-401.

    PMID: 10413832BACKGROUND

  • Leutmezer F, Schernthaner C, Lurger S, Potzelberger K, Baumgartner C. Electrocardiographic changes at the onset of epileptic seizures. Epilepsia. 2003 Mar;44(3):348-54. doi: 10.1046/j.1528-1157.2003.34702.x.

    PMID: 12614390BACKGROUND

  • Di Gennaro G, Quarato PP, Sebastiano F, Esposito V, Onorati P, Grammaldo LG, Meldolesi GN, Mascia A, Falco C, Scoppetta C, Eusebi F, Manfredi M, Cantore G. Ictal heart rate increase precedes EEG discharge in drug-resistant mesial temporal lobe seizures. Clin Neurophysiol. 2004 May;115(5):1169-77. doi: 10.1016/j.clinph.2003.12.016.

    PMID: 15066542BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Douglas Denham, DO

    Clinical Trails of Texas, Inc.

    PRINCIPAL INVESTIGATOR

  • Bryan Olin, Ph.D

    Cyberonics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2011

First Posted

December 6, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

US(1)