Neurostimulation for the Relief of Acute Bronchoconstriction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma

NCT01385306

Asthma

TERMINATED NA

Sustained Auricular Nerve Stimulation for PVC Suppression

NCT07093034

Premature Ventricular Complexes PVC - Premature Ventricular Contraction Auricular Vagus Nerve Stimulation

ENROLLING_BY_INVITATION NA

Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial

NCT07133932

Cerebral Infarction Mechanical Ventilation Acute Cerebrovascular Accident +1 more

NOT_YET_RECRUITING NA

Mapping for Acute Transvenous Phrenic Nerve Stimulation Study

NCT01981590

Sleep Apnea

COMPLETED NA

Vagal Nerve Stimulation as an Alternative Therapy for Premature Ventricular Contractions

NCT06110364

Premature Ventricular Contraction

WITHDRAWN PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Resolve Stimulator and Proximity Lead

Intervention Type DEVICE

An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Resolve Stimulator and Proximity Lead

An electrical neurostimulation signal will be applied to the neck via subcutaneous lead placement for vagal nerve stimulation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No