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Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

This study is currently recruiting participants.
Verified April 2013 by Cyberonics, Inc.
Sponsor:
Information provided by (Responsible Party):
Cyberonics, Inc.
ClinicalTrials.gov Identifier:
NCT01626599
First received: June 15, 2012
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is designed to collect data to support development of a novel product designed to capture ECG signals and accelerometer data.


Condition Intervention
Epilepsy
 Device: Cyberonics Investigational Accelerometry Device & Cyberonics Investigational Weighted Simulant Device

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study to Evaluate a Baseline Prototype Device Designed to Collect ECG (Electrocardiogram) and Accelerometer Data

Resource links provided by NLM:

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Further study details as provided by Cyberonics, Inc.:

Primary Outcome Measures:
  • Collection of ECG and accelerometer data [ Time Frame: Up to 9 days (+/-1 day) ] [ Designated as safety issue: No ]
    This study is designed to collect data to support development of a novel product designed to capture ECG signals and accelerometer data.


Secondary Outcome Measures:
  • Device wearability [ Time Frame: Up to 9 days (+/-1 day) ] [ Designated as safety issue: No ]
    Device adhesion and dermal response


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1:Adult Healthy Subjects Device: Cyberonics Investigational Accelerometry Device & Cyberonics Investigational Weighted Simulant Device

These investigational devices are applied externally and worn for up to 9 days (+/- 1 day). These investigational devices are non-significant risk (NSR) because they do not present a potential for serious risk to health, safety or welfare of a human subject, specifically the devices:

  • are not implantable and no surgical procedure is required for a human subject to use the devices;
  • are not for use in supporting or sustaining a human life;
  • are not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; and
  • contain skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.
Group 2:Adult Epilepsy Subjects Device: Cyberonics Investigational Accelerometry Device & Cyberonics Investigational Weighted Simulant Device

These investigational devices are applied externally and worn for up to 9 days (+/- 1 day). These investigational devices are non-significant risk (NSR) because they do not present a potential for serious risk to health, safety or welfare of a human subject, specifically the devices:

  • are not implantable and no surgical procedure is required for a human subject to use the devices;
  • are not for use in supporting or sustaining a human life;
  • are not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; and
  • contain skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.
Group 3:Pediatric Epilepsy Subjects Device: Cyberonics Investigational Accelerometry Device & Cyberonics Investigational Weighted Simulant Device

These investigational devices are applied externally and worn for up to 9 days (+/- 1 day). These investigational devices are non-significant risk (NSR) because they do not present a potential for serious risk to health, safety or welfare of a human subject, specifically the devices:

  • are not implantable and no surgical procedure is required for a human subject to use the devices;
  • are not for use in supporting or sustaining a human life;
  • are not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; and
  • contain skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.
Group 4:Pediatric Healthy Subjects Device: Cyberonics Investigational Accelerometry Device & Cyberonics Investigational Weighted Simulant Device

These investigational devices are applied externally and worn for up to 9 days (+/- 1 day). These investigational devices are non-significant risk (NSR) because they do not present a potential for serious risk to health, safety or welfare of a human subject, specifically the devices:

  • are not implantable and no surgical procedure is required for a human subject to use the devices;
  • are not for use in supporting or sustaining a human life;
  • are not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health; and
  • contain skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.

Detailed Description:

This is a prospective, non-interventional, observational, un-blinded, non-significant risk, multi-site study designed to collect ECG and accelerometer data using an Investigational device on subjects in multiple study stages.

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population will consist of healthy adults and children and adults and children with Epilepsy.

Criteria

Inclusion Criteria:

  • Five (5) years of age or older
  • Good general health and fully ambulatory

Epilepsy arm must also meet the following inclusion criteria:

  • A clinical diagnosis of epilepsy
  • Currently taking at least one antiepileptic medication

Exclusion Criteria:

  • Any visible skin disorder, condition, or abnormal skin pigmentation which, in the investigators opinion, would interfere with the outcome of the trial.
  • Known sensitivity or history of irritation to adhesive tape (Latex), topically applied products
  • Existing defibrillator, pacemakers, or VNS Therapy System
  • Cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate during normal activities. This would include but not be limited to chronic atrial fibrillation or chronotropic incompetence.
  • Severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
  • Pregnant and or nursing women (verified by a urine pregnancy test).
  • Currently participating in another clinical study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626599

Contacts
Contact: Jeff Way, Clinical Study Manager (800) 332-1375 ext 7394 Jeffrey.way@cyberonics.com

Locations
United States, Illinois
United States, Illinois Recruiting
Chicago, Illinois, United States, 60654
United States, Texas
United States, Texas Recruiting
Austin, Texas, United States, 78731
United States, Texas Recruiting
Houston, Texas, United States, 77054
United States, Texas Recruiting
Houston, Texas, United States, 77034
United States, Texas Not yet recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Cyberonics, Inc.
Investigators
Study Director: Bryan Olin, Ph.D. Cyberonics, Inc.
  More Information

No publications provided

Responsible Party: Cyberonics, Inc.
ClinicalTrials.gov Identifier: NCT01626599     History of Changes
Other Study ID Numbers: PG-01
Study First Received: June 15, 2012
Last Updated: April 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cyberonics, Inc.:
ECG
Accelerometer
Device

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013