NCT00762931

Neurostimulation for the Relief of Acute Bronchoconstriction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: ElectroCore INC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DEVICE	Resolve Stimulator and Proximity Lead	An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-09-01
• Completion: 2010-10-01
• First posted: 2008-09-30
• Last updated: 2018-05-15
• Results posted: 2018-05-15

Locations

6 sites across 1 country: United States