Status:
COMPLETED
Neurostimulation for the Relief of Acute Bronchoconstriction
Lead Sponsor:
ElectroCore INC
Conditions:
Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 el...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00762931
Start Date
September 1 2008
End Date
October 1 2010
Last Update
May 15 2018
Active Locations (6)
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1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Henry Ford Health System
Detroit, Michigan, United States, 48202
3
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
4
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415