Neurostimulation for the Relief of Acute Bronchoconstriction

ElectroCore

Status: Completed

Conditions: Asthma

Treatments: Device: Resolve Stimulator and Proximity Lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762931

BC-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Resolve Stimulator and Proximity Lead

Experimental group

Description:

An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment

Treatment:

Device: Resolve Stimulator and Proximity Lead