Neurostimulation for the Relief of Acute Bronchoconstriction
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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 |
- 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 ]
- 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 |
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| 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 | |
| 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: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ElectroCore LLC:
|
bronchoconstriction neuromodulation neurostimulation |
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 May 22, 2013