Noninvasive Neurostimulation of the Vagus Nerve for the Relief of Acute Bronchoconstriction Due to Asthma (BC-SA-01)
This study has suspended participant recruitment.
Information provided by (Responsible Party):
First received: June 17, 2011
Last updated: December 12, 2011
Last verified: December 2011
The objective of this feasibility research study is to gather preliminary clinical data regarding the safety and potential clinical benefit of noninvasive neurostimulation of the vagus nerve with the AlphaCore™ system for the relief of acute bronchoconstriction due to asthma.
Device: AlphaCore System
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Noninvasive Neurostimulation of the Vagus Nerve With the AlphaCore System for the Relief of Acute Bronchoconstriction Due to Asthma
Primary Outcome Measures:
Secondary Outcome Measures:
- Improvement of FEV1 [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Improvement with Dyspnea Score [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
- Time to discharge from the emergency department [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
- Requirement for concomitant medications [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||May 2012 (Final data collection date for primary outcome measure)
Device: AlphaCore System
Non-invasive neurostimulation of the vagus nerve
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Is between the ages of 18 and 70 years.
- Has been admitted to an emergency care facility with a working diagnosis of bronchoconstriction due to asthma.
- Has an FEV1<60% predicted.
- Is available and willing to return for an office visit at 7 days and participate in a 30-day telephone call from time of discharge from the ED.
- Is able to give written Informed Consent, or his/her legally authorized representative is available to give written Informed Consent.
- Has a history of lung cancer, chronic obstructive pulmonary disease (COPD), or other co-morbidity due to irreversible narrowing of the airways.
Is at risk of imminent respiratory collapse:
- Lung Function: FEV1 < 25% predicted
- Signs and symptoms of extreme respiratory distress at rest, such as accessory muscle use, chest retraction
- Consciousness State: Drowsy, confused
- Rapid deterioration in respiratory status (sudden change in respiratory rate, decrease in oxygen saturation, change in consciousness, etc).
- Has an abscess or other infection or lesion (including lymphadenopathy) at the therapy head placement site.
- Has known or suspected atherosclerotic cardiovascular disease, carotid artery disease (e.g. bruits or history of TIA or CVA) or congestive heart failure (CHF).
- Has suspected or confirmed sepsis.
- Has a clinically significant irregular heart rate or rhythm.
- Clinically significant changes in blood pressure or is receiving pressors to maintain blood pressure.
- Is currently implanted with an 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.
- Has a history of carotid endarterectomy or vascular neck surgery on the right side.
- Has been implanted with metal cervical spine hardware.
- Has a condition that would interfere with VAS Dyspnea self-assessment.
- Is pregnant.
- Is participating in any other therapeutic clinical investigation or has participated in a clinical trial in the preceding 30 days.
- Belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g., homeless, developmentally disabled, prisoner).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01385306
|Kuils River, Cape Town, South Africa, 7580 |
|Panaroma, Cape Town, South Africa, 7500 |
|Life Vincent Pallotti Hospital
|Pinelands, Cape Town, South Africa, 7405 |
|Cape Gate Medi-Clinic Hospital
|Stellenbosch, Cape Town, South Africa, 7600 |
|Christiaan Barnard Memorial Hospital
|Cape Town, South Africa, 8001 |
||Elmin Steyn, MD
||Zunaid Mohammed, MD
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 17, 2011
||December 12, 2011
||South Africa: Department of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 16, 2013
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases