AsthmaNCT00762931
Neurostimulation for the Relief of Acute Bronchoconstriction
A study testing Resolve Stimulator and Proximity Lead in people with Asthma, run by ElectroCore INC at 6 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Resolve Stimulator and Proximity Lead
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2008to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Rush University Medical Center
Chicago, Illinois, 60612
Henry Ford Health System
Detroit, Michigan, 48202
Dorrington Medical Associates
Houston, Texas, 77030
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
William Beaumont Hospital
Royal Oak, Michigan, 48073
Washington University School of Medicine, Barnes-Jewish Hospital,
St Louis, Missouri, 63110
About this study
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.
Read the 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
- Being tested
- Resolve Stimulator and Proximity Lead
- Keywords
- bronchoconstriction, neuromodulation, neurostimulation, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive, gammacore
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resolve Stimulator and Proximity LeadDevice
An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Resolve Stimulator and Proximity Lead | Experimental | An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment Receives: Device: Resolve Stimulator and Proximity Lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety- Number of Participants With Adverse Events
Safety- Number of participants that reported Adverse Events
Measured: 2 weeks
Secondary outcomes (1)
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).
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%.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionSep 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- ElectroCore INC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JP Errico, Study director, ElectroCore INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00762931
- Sponsor's protocol ID
- BC-01
- Status last verified
- Apr 2018
- First submitted
- 29 Sep 2008
- Last updated
- 15 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurostimulation for the Relief of Acute Bronchoconstriction
- ClinicalTrials.gov ID
- NCT00762931
- Acronym / sponsor ID
- BC-01
- Conditions
- Asthma
- Keywords
- bronchoconstriction, neuromodulation, neurostimulation, vagus nerve stimulation, vagal nerve stimulation, nVNS, VNS, non invasive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- ElectroCore INCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 30 Sep 2008 (estimated)
- Results
- Posted 15 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resolve Stimulator and Proximity Lead | Experimental | Device: Resolve Stimulator and Proximity LeadAn electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation, all subjects will receive active treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resolve Stimulator and Proximity LeadAn electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation | Device | Resolve Stimulator and Proximity Lead |
Primary outcome
Safety- Number of Participants With Adverse Events
Time frame: 2 weeks
Safety- Number of participants that reported Adverse Events
1 secondary outcome
Improvement of Common Measures of Breathing Performance, Forced Expiry Volume in 1second (FEV1).
Time frame: 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JP Errico study director
ElectroCore INC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resolve Stimulator and Proximity Lead in people with Asthma, run by ElectroCore INC at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety- Number of Participants With Adverse Events (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.