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Neurostimulation for the Relief of Acute Bronchoconstriction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00762931
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Information provided by (Responsible Party):
ElectroCore INC

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Device: Resolve Stimulator and Proximity Lead Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurostimulation for the Relief of Acute Bronchoconstriction
Study Start Date : September 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: Resolve Stimulator and Proximity Lead
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment
Device: Resolve Stimulator and Proximity Lead
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

Primary Outcome Measures :
  1. Safety- Number of Participants With Adverse Events [ Time Frame: 2 weeks ]
    Safety- Number of participants that reported Adverse Events

Secondary Outcome Measures :
  1. Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1). [ Time Frame: 60 minutes ]

    An assessment of Forced Expiry Volume in 1second (FEV1) measurements were taken throughout the course of treatment (15,30 and 60 minutes).

    Peak FEV1 measurements were recorded for each subject, and the number of minutes the subject had received treatment at the time of peak FEV1.

    The threshold for improvement was set at 12% over baseline at any of the time points (15,30 and 60 minutes). Outcome measure data indicates the number of subjects above 12%.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00762931

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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,
Saint Louis, Missouri, United States, 63110
United States, Texas
Dorrington Medical Associates
Houston, Texas, United States, 77030
Sponsors and Collaborators
ElectroCore INC
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Study Director: JP Errico ElectroCore INC
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Responsible Party: ElectroCore INC Identifier: NCT00762931    
Other Study ID Numbers: BC-01
First Posted: September 30, 2008    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by ElectroCore INC:
vagus nerve stimulation
vagal nerve stimulation
non invasive