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.|
|ClinicalTrials.gov Identifier: NCT00762931|
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Device: Resolve Stimulator and Proximity Lead||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- Safety- Number of Participants With Adverse Events [ Time Frame: 2 weeks ]Safety- Number of participants that reported Adverse Events
- 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%.
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 ClinicalTrials.gov identifier (NCT number): NCT00762931
|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|
|Study Director:||JP Errico||ElectroCore INC|