Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Ohio State University
Sponsor:
Information provided by (Responsible Party):
Jonathan Parsons, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01724307
First received: October 9, 2012
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The purpose of this study is to evaluate if stimulating the nerve involved with airway constriction, while undergoing procedures that are known to cause asthma exacerbations, decreases the level of asthma attack experienced.


Condition Intervention
Asthma
Procedure: Neurostimulation of stellate ganglion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma.

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Evaluate if neurostimulation of stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing. Comparison of FEV1 drop before and after neurostimulation testing will be primary outcome measure [ Time Frame: 60 minutes post treatment ] [ Designated as safety issue: No ]
    To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics


Secondary Outcome Measures:
  • Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation [ Time Frame: 60 minutes post treatment ] [ Designated as safety issue: No ]
    To determine whether neurostimulation of the stellate ganglion modulates airway inflammation as measured by exhaled nitric oxide in asthmatics


Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Asthma positive to Methacholine Challenge Testing
Asthma diagnosis by positive Methacholine Challenge Testing
Procedure: Neurostimulation of stellate ganglion
An electrical nuerostimulation of the stellate ganglion up to 60 minutes
Active Comparator: Asthma positive to Eucapnic voluntary hyperventilation testing
Asthma diagnosis by positive Eucapnic voluntary hyperventilation testing
Procedure: Neurostimulation of stellate ganglion
An electrical nuerostimulation of the stellate ganglion up to 60 minutes

Detailed Description:

Asthma is a chronic inflammatory disorder of the airways characterized by shortness of breath, wheezing, cough, and fatigue. Some people suffer from sudden worsening of asthma symptoms despite being treated with medications. When people have asthma attacks the muscle tissue in the airway contracts causing the airway to narrow and decreasing the ability for the person to breathe.

Neurological pacemakers are FDA approved devices that stimulate nerves in the body and have been used for the treatment of many disorders such as Parkinson's, epilepsy, chronic pain and urinary incontinence. Recent animal studies have shown that stimulating (activating a nerve) the carotid sheath area (located in the neck) can cause the rapid relaxation of the muscles which contract during an asthma attack. This approach has also been successfully used in patients at an emergency room when they came in with a severe asthma attack.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients aged 18-70 years of age suffering from mild-to-moderate asthma who have either:

    1. bronchial hyper-responsiveness to MCT
    2. bronchial hyper-responsiveness to EVH testing
  2. All patients with documented evidence of a positive MCT or EVH test within 36 months of Visit 1
  3. Are capable of reading and understanding questionnaires and providing written informed consent.
  4. Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.

Exclusion Criteria:

  1. Non-English speaking.
  2. Subjects experiencing an exacerbation of asthma within 6 weeks of Visit 1
  3. Subjects with a forced expiratory volume (FEV1) ≤ 60% predicted, on spirometry
  4. Subjects and medications:

    1. Subjects allergic to methacholine or any other parasympathomimetic agent
    2. Subjects on investigational drugs or participating in interventional research trial(s), 30 days prior to enrollment or during the duration of the study
    3. Subjects currently on β-adrenergic blockers or, a cholinesterase inhibitor
    4. Prior to the administering of the MCT/ EVH test:

    i) use of a short-acting bronchodilator (within 6hrs.) ii) use of a long-acting bronchodilator (within 36hrs.) iii) use of inhaled corticosteroids/ leukotriene modifiers (within 72hrs.) iv) exercise (within 4hrs.)

  5. Subject smoking: in the last 6 months or a smoking history of >10 pack-years
  6. Subjects who have experienced a febrile illness within 3 weeks of Visit 1
  7. Subjects with a history of active poorly controlled epilepsy, cardiovascular disease (esp. with bradycardia), vagotonia, peptic ulcer disease, thyroid disease, or urinary tract obstruction or other chronic ailments that would interfere with the current study
  8. Subjects who are pregnant or refuse medically acceptable contraception during the study period
  9. Subjects with a history of >3 stellate ganglion block procedures
  10. Subjects who have undergone surgical procedures involving the cervical spine
  11. Evidence of coagulopathy with abnormal INR, PT/ PTT and platelet count
  12. Subjects allergic to lidocaine (Subject may still participate in the study if they agree to the procedure without using the Lidoderm patch)
  13. Subjects participating in another interventional research trial
  14. Subjects with a condition or compliance issue, which in the investigator's opinion might interfere with participation in the current study
  15. Subjects unable or unwilling to provide a written consent to undergo the required testing/ procedures/ physical exam or answer the questionnaires
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724307

Contacts
Contact: Pulmonary Clinical Trials Office 614-293-4978 Lung.Research@osumc.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43221
Contact: Pulmonary Clinical Trials Office    614-293-4978    Lung.Research@osumc.edu   
Principal Investigator: Jonathan P Parsons, M.D.         
Sponsors and Collaborators
Jonathan Parsons
Investigators
Principal Investigator: Jonathan P Parsons, M.D. Ohio State University
  More Information

No publications provided

Responsible Party: Jonathan Parsons, M.D., The Ohio State University
ClinicalTrials.gov Identifier: NCT01724307     History of Changes
Other Study ID Numbers: 2011H0009
Study First Received: October 9, 2012
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Asthma
Ganglion Cysts
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 26, 2014