Neurostimulation for the Relief of Acute Bronchoconstriction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ElectroCore LLC
ClinicalTrials.gov Identifier:
NCT00762931
First received: September 29, 2008
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.


Condition Intervention Phase
Asthma
Device: Neurostimulation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neurostimulation for the Relief of Acute Bronchoconstriction

Resource links provided by NLM:


Further study details as provided by ElectroCore LLC:

Primary Outcome Measures:
  • Validate design for the Stimulator and Electrode and the associated procedure to safely position it into the neck by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement of common measures of breathing performance (FEV1). [ Time Frame: 30 minutes post treatment ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurostimulation
All subjects will receive active treatment
Device: Neurostimulation
An electrical neurostimulation signal will be applied to the neck.
Other Name: ElectroCore Resolve Stimulator and Proximity Lead
Device: Neurostimulation
Subcutaneous lead placement for vagal nerve stimulation

Detailed Description:

The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck.

Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male / Female, Age 18-65
  • Subject declares a medical history of asthma or sufficient prior clinical experience/records exists to confirm the subject has received a diagnosis of bronchoconstriction
  • Completed >1 hrs of conventional breathing and related medication treatments without improvement in FEV1 to > 70% predicted
  • Able to give Informed Consent

Exclusion Criteria:

  • Scaring / abscess other problems with neck at electrode placement site
  • Known or suspected carotid artery disease (i.e. bruits or history of stenosis)
  • Suspected or confirmed coagulopathy
  • Suspected or confirmed sepsis
  • Irregular heart rate, rhythm
  • Receiving pressors to maintain blood pressure
  • Presently implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
  • Allergy to local anesthetics used for placement of the lead
  • History of lung cancer, emphysema, chronic obstructive pulmonary disease, or other comorbidity that might otherwise compromise the expected air flow volumes in the lungs
  • At risk of imminent respiratory collapse

    • Lung Function: FEV1 < 40% predicted
    • Signs and Symptoms: Extreme symptoms at rest, accessory muscle use, chest retraction
    • Alert State: Drowsy, confused
  • Treatment with anti-cholinergic medications within 4 hours of enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00762931

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
United States, Missouri
Washington University School of Medicine, Barnes-Jewish Hospital,
St Louis, Missouri, United States, 63110
United States, Texas
Dorrington Medical Associates
Houston, Texas, United States, 77030
Sponsors and Collaborators
ElectroCore LLC
Investigators
Study Director: JP Errico ElectroCore LLC
  More Information

No publications provided

Responsible Party: ElectroCore LLC
ClinicalTrials.gov Identifier: NCT00762931     History of Changes
Other Study ID Numbers: BC-01
Study First Received: September 29, 2008
Last Updated: October 4, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ElectroCore LLC:
bronchoconstriction
neuromodulation
neurostimulation
vagus nerve stimulation
vagal nerve stimulation
nVNS
VNS
non invasive
gammacore

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014