Spinal Cord InjuriesNCT00589199
Functional Electrical Stimulation for Production of Artificial Cough
A study testing Placement and use of the device in people with Spinal Cord Injuries and Paralysis, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
The purpose of the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Paralysis
- What is being tested?
- Placement and use of the device
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1993to Jan 2010
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with cervical or thoracic spinal cord injury
Who cannot join
- Significant cardiovascular disease
- Active lung disease
- Pacemaker or other metallic implant
- Legally incompetent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory complications such as atelectasis, respiratory tract infections and respiratory failure.
Read the detailed description
Cough is a complex defensive respiratory reflex mechanism necessary for the clearance of respiratory secretions and foreign materials. In patients with chronic bronchitis, previous investigations have found that the cough mechanism is the most effective measure to enhance mucous clearance from the lung.
Patients with cervical and thoracic spinal cord injuries have suffered a loss of the major portion of their expiratory muscles. Consequently, they are unable to generate significant positive intrathoracic airway pressures or airflow and have a markedly increased risk of developing pulmonary infections. Mechanical methods have been developed to enhance cough production. However, these have resulted in only marginal increases in airway pressure.
Preliminary studies in our laboratory in animal experiments and those of others in humans have suggested that the abdominal muscles can be stimulated directly by surface electrodes. The purpose of the present study, therefore, is to assess the utility of abdominal muscle stimulation in quadriplegics and paraplegics to simulate cough. A range of stimulus parameters and electrode locations will be assessed to determine optimal stimulus paradigms. Airway pressure and expiratory airflow will be used as indices of cough effectiveness. If successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully reduce the incidence of respiratory complications such as atelectasis and infection in spinal cord injured patients.
- Conditions
- Spinal Cord Injuries, Paralysis
- Being tested
- Placement and use of the device
- Medical subject headings
- Spinal Cord Injuries, Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement and use of the deviceProcedure or surgery
Surface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Functional Electrical Stimulation for Production of Artificial Cough Receives: Procedure: Placement and use of the device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough
Measured: one year
Secondary outcomes (1)
Incidence of respiratory complications
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2008 (estimated)
- Study startDec 1993
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony F. Dimarco, MetroHealth Medical Center
- Investigators
- Anthony F DiMarco, MD, Principal investigator, MetroHealth Medical Center and Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00589199
- Sponsor's protocol ID
- IRB93-00133
- Status last verified
- Jul 2019
- First submitted
- 21 Dec 2007
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Electrical Stimulation for Production of Artificial Cough
- ClinicalTrials.gov ID
- NCT00589199
- Acronym / sponsor ID
- IRB93-00133
- Conditions
- Spinal Cord Injuries, Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- Dec 1993
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Jan 2008 (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 the present study is to assess the utility of abdominal muscle stimulation to provide large positive airway pressures and expiratory airflow thus simulating cough. Restoration of cough in spinal cord injured patients may reduce the incidence of respiratory complications such as atelectasis, respiratory tract infections and respiratory failure.
Detailed description
Cough is a complex defensive respiratory reflex mechanism necessary for the clearance of respiratory secretions and foreign materials. In patients with chronic bronchitis, previous investigations have found that the cough mechanism is the most effective measure to enhance mucous clearance from the lung.
Patients with cervical and thoracic spinal cord injuries have suffered a loss of the major portion of their expiratory muscles. Consequently, they are unable to generate significant positive intrathoracic airway pressures or airflow and have a markedly increased risk of developing pulmonary infections. Mechanical methods have been developed to enhance cough production. However, these have resulted in only marginal increases in airway pressure.
Preliminary studies in our laboratory in animal experiments and those of others in humans have suggested that the abdominal muscles can be stimulated directly by surface electrodes. The purpose of the present study, therefore, is to assess the utility of abdominal muscle stimulation in quadriplegics and paraplegics to simulate cough. A range of stimulus parameters and electrode locations will be assessed to determine optimal stimulus paradigms. Airway pressure and expiratory airflow will be used as indices of cough effectiveness. If successful, abdominal muscle stimulation may be a useful tool to restore cough and hopefully reduce the incidence of respiratory complications such as atelectasis and infection in spinal cord injured patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Placement and use of the deviceFunctional Electrical Stimulation for Production of Artificial Cough |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with cervical or thoracic spinal cord injury
Key exclusion criteria (4 listed)
- Significant cardiovascular disease
- Active lung disease
- Pacemaker or other metallic implant
- Legally incompetent
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 |
|---|---|---|
| Placement and use of the deviceSurface electrodes currently used for peripheral muscle stimulation by other groups will be applied to the abdominal wall and over the posterior lower thoracic rib cage. Between two and three pairs (anodic and cathodic) of electrodes will be used in combination to activate the expiratory muscles. Electrodes will be positioned at various points over the abdominal wall and the posterior thoracic rib cage to ascertain optimal placement for airway pressure and expiratory airflow generation. The electrical stimulators to be used (EMPI and NeuroMedic) are powered by 9-volt batteries. These stimulators are currently in clinical use to stimulate other skeletal muscles and are known to be quite safe. | Procedure or surgery | 1 |
Primary outcome
Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough
Time frame: one year
1 secondary outcome
Incidence of respiratory complications
Time frame: one year
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 2 Aug 2019.
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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.
Anthony F DiMarco, MD principal investigator
MetroHealth Medical Center and Case Western Reserve 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 Placement and use of the device in people with Spinal Cord Injuries and Paralysis, run by MetroHealth Medical Center 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 1 inclusion and 4 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 2 Aug 2019. 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?
Measurements of airway pressure and expiratory flow rate to evaluate efficacy of cough (time frame: one year). 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 2 Aug 2019.