AsthmaNCT01724307
Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma
A study testing Neurostimulation of stellate ganglion in people with Asthma, run by Jonathan Parsons at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Neurostimulation of stellate ganglion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged 18-70 years of age suffering from mild-to-moderate asthma who have either:
- bronchial hyper-responsiveness to MCT
- bronchial hyper-responsiveness to EVH testing
- All patients with documented evidence of a positive MCT or EVH test within 36 months of Visit 1
- Are capable of reading and understanding questionnaires and providing written informed consent.
- Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.
Who cannot join
- Non-English speaking.
- Subjects experiencing an exacerbation of asthma within 6 weeks of Visit 1
- Subjects with a forced expiratory volume (FEV1) ≤ 60% predicted, on spirometry
- Subjects and medications:
- Subjects allergic to methacholine or any other parasympathomimetic agent
- Subjects on investigational drugs or participating in interventional research trial(s), 30 days prior to enrollment or during the duration of the study
Show all 20Show fewer
- Subjects currently on β-adrenergic blockers or, a cholinesterase inhibitor
- Prior to the administering of the MCT/ EVH test:
- 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.)
- Subject smoking: in the last 6 months or a smoking history of >10 pack-years
- Subjects who have experienced a febrile illness within 3 weeks of Visit 1
- 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
- Subjects who are pregnant or refuse medically acceptable contraception during the study period
- Subjects with a history of >3 stellate ganglion block procedures
- Subjects who have undergone surgical procedures involving the cervical spine
- Evidence of coagulopathy with abnormal INR, PT/ PTT and platelet count
- Subjects allergic to lidocaine (Subject may still participate in the study if they agree to the procedure without using the Lidoderm patch)
- Subjects participating in another interventional research trial
- Subjects with a condition or compliance issue, which in the investigator's opinion might interfere with participation in the current study
- Subjects unable or unwilling to provide a written consent to undergo the required testing/ procedures/ physical exam or answer the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma.
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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Neurostimulation of stellate ganglion
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulation of stellate ganglionProcedure or surgery
An electrical nuerostimulation of the stellate ganglion up to 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Asthma positive to Methacholine Challenge Testing | Active comparator | Asthma diagnosis by positive Methacholine Challenge Testing Receives: Procedure: Neurostimulation of stellate ganglion |
| Asthma positive to Eucapnic voluntary hyperventilation testing | Active comparator | Asthma diagnosis by positive Eucapnic voluntary hyperventilation testing Receives: Procedure: Neurostimulation of stellate ganglion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics
Measured: 60 minutes post treatment
Secondary outcomes (1)
Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation
To determine whether neurostimulation of the stellate ganglion modulates airway inflammation as measured by exhaled nitric oxide in asthmatics
Measured: 60 minutes post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2012 (estimated)
- Study startSep 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Parsons
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jonathan Parsons, Ohio State University
- Investigators
- Jonathan P Parsons, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01724307
- Sponsor's protocol ID
- 2011H0009
- Status last verified
- Jan 2016
- First submitted
- 9 Oct 2012
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulation of the Cervical Sympathetic Ganglion for Treatment of Asthma.
- ClinicalTrials.gov ID
- NCT01724307
- Acronym / sponsor ID
- 2011H0009
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Jonathan ParsonsUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 9 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma positive to Methacholine Challenge Testing | Active comparator | Procedure: Neurostimulation of stellate ganglionAsthma diagnosis by positive Methacholine Challenge Testing |
| Asthma positive to Eucapnic voluntary hyperventilation testing | Active comparator | Procedure: Neurostimulation of stellate ganglionAsthma diagnosis by positive Eucapnic voluntary hyperventilation testing |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients aged 18-70 years of age suffering from mild-to-moderate asthma who have either:
- All patients with documented evidence of a positive MCT or EVH test within 36 months of Visit 1
- Are capable of reading and understanding questionnaires and providing written informed consent.
- Are willing and able to adhere to the study visit schedule and other protocol-specified procedures.
Key exclusion criteria (20 listed)
- Non-English speaking.
- Subjects experiencing an exacerbation of asthma within 6 weeks of Visit 1
- Subjects with a forced expiratory volume (FEV1) ≤ 60% predicted, on spirometry
- Subjects and medications:
- Subject smoking: in the last 6 months or a smoking history of >10 pack-years
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 |
|---|---|---|
| Neurostimulation of stellate ganglionAn electrical nuerostimulation of the stellate ganglion up to 60 minutes | Procedure or surgery | Asthma positive to Eucapnic voluntary hyperventilation testing, Asthma positive to Methacholine Challenge Testing |
Primary outcome
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
To determine whether neurostimulation of the stellate ganglion modulates airway hyperresponsiveness to bronchoprovocation testing in asthmatics
1 secondary outcome
Evaluate if neurostimulation of the stellate ganglion modulates airway inflammation
Time frame: 60 minutes post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Jonathan P Parsons, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurostimulation of stellate ganglion in people with Asthma, run by Jonathan Parsons at 1 site 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 6 inclusion and 20 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 27 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). 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 27 Jan 2016.