Spinal Cord InjuriesNCT00995215
Sub-study to Spinal Cord Stimulation to Restore Cough
A study testing Spinal Cord Stimulation and Expiratory Muscle Stimulator in people with Spinal Cord Injuries and Spinal Cord Diseases, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis
- What is being tested?
- Spinal Cord Stimulation and Expiratory Muscle Stimulator
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to 31 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Stable spinal cord injury T5 level or higher
- Expiratory muscle weakness
Who cannot join
- Significant cardiovascular disease
- Active lung disease
- Brain disease
- Scoliosis, chest wall deformity, or marked obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Read the detailed description
Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. In fact, pneumonia is a major cause of death in this patient population.
In a recent clinical trial, we have shown that the expiratory muscles can be electrically activated by spinal cord stimulation (SCS), a technique which involves the surgical placement of disc electrodes on the surface of the spinal cord. This method is successful in achieving an effective means of expiratory muscle activation, as demonstrated by the generation of large airway pressures and peak airflow rates. Importantly, SCS facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. This method therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects.
The purpose of this trial is to directly compare activation of the expiratory muscles using wire electrodes, which can be inserted percutaneously through a needle, with the previously employed disc electrodes.
In this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation including medical history, a brief physical examination, and initial testing, each participant will undergo a surgical procedure to implant small electrodes (metal discs) over the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. Prior to permanent implantation of this system, wire and disc electrodes will be compared by assessing the degree of expiratory muscle activation with each electrode type. The disc electrodes will then be permanently implanted, allowing the participant to have use of a fully functioning stimulation system to restore an effective cough.
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough
- Being tested
- Spinal Cord Stimulation, Expiratory Muscle Stimulator
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationProcedure or surgery
Also called NeuroControl Expiratory Muscle Stimulation (IDE G980267)
The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit.
Expiratory Muscle StimulatorDevice
The expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit. Receives: Procedure: Spinal Cord Stimulation; Device: Expiratory Muscle Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes
The effects of SCS with temporarily placed parallel wire leads and then with permanently implanted disc electrodes on airway pressure generation in each participant was evaluated in the operating room. The wire electrodes were temporarily placed (immediately prior to placement of disc electrodes as part of the current clinical trial) over the surface of the spinal cord on the lower back. These electrodes were activated, and the degree of expiratory muscle activation were assessed. The wire electrodes were then removed. Small, disc electrodes were then permanently implanted to stimulate expiratory muscles and restore cough. All measurements were repeated. Since SCS with the disc electrode leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.
Measured: intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2009
- Primary completion15 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Principal investigator, Anthony F. Dimarco, MetroHealth Medical Center
- Investigators
- Anthony F. DiMarco, MD, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995215
- Sponsor's protocol ID
- IRB08-00269/IRB98-00091
- Other IDs
- IRB08-00269, IRB98-00091
- Status last verified
- Apr 2020
- First submitted
- 14 Oct 2009
- Last updated
- 14 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
PubMed 19406289DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
PubMed 19406290
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
- ClinicalTrials.gov ID
- NCT00995215
- Acronym / sponsor ID
- IRB08-00269/IRB98-00091
- Conditions
- Spinal Cord Injuries, Spinal Cord Diseases, Paralysis, Central Nervous System Diseases, Cough
- Keywords
- spinal cord injury, paralysis, cough, cervical spinal cord injury, thoracic spinal cord injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2009
- Primary completion
- 15 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Posted 14 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of Wire Electrodes to Activate the Expiratory Muscles to Restore Cough
Detailed description
Patients with cervical and thoracic spinal cord injuries often have paralysis of a major portion of their expiratory muscles - the muscles responsible for coughing - and therefore, lack a normal cough mechanism. Consequently, most of these patients suffer from a markedly reduced ability to clear airway secretions, a factor which contributes to the development of recurrent respiratory tract infections such as pneumonia and bronchitis. In fact, pneumonia is a major cause of death in this patient population.
In a recent clinical trial, we have shown that the expiratory muscles can be electrically activated by spinal cord stimulation (SCS), a technique which involves the surgical placement of disc electrodes on the surface of the spinal cord. This method is successful in achieving an effective means of expiratory muscle activation, as demonstrated by the generation of large airway pressures and peak airflow rates. Importantly, SCS facilitates secretion removal, reduces the need for caregiver support, reduces the incidence of respiratory tract infections and improves life quality. This method therefore has the potential to reduce health care costs and improve survival in spinal cord injured subjects.
The purpose of this trial is to directly compare activation of the expiratory muscles using wire electrodes, which can be inserted percutaneously through a needle, with the previously employed disc electrodes.
In this trial, researchers will study 6 adults (18-70 years old) with spinal injuries (T5 level or higher), at least 12 months following the date of injury. After an evaluation including medical history, a brief physical examination, and initial testing, each participant will undergo a surgical procedure to implant small electrodes (metal discs) over the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. Prior to permanent implantation of this system, wire and disc electrodes will be compared by assessing the degree of expiratory muscle activation with each electrode type. The disc electrodes will then be permanently implanted, allowing the participant to have use of a fully functioning stimulation system to restore an effective cough.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Procedure: Spinal Cord Stimulation, Device: Expiratory Muscle StimulatorThe participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stable spinal cord injury T5 level or higher
- Expiratory muscle weakness
Key exclusion criteria (4 listed)
- Significant cardiovascular disease
- Active lung disease
- Brain disease
- Scoliosis, chest wall deformity, or marked obesity
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 |
|---|---|---|
| Spinal Cord StimulationAlso: NeuroControl Expiratory Muscle Stimulation (IDE G980267)The participant will have wire electrodes temporarily placed - by a routine surgical procedure - over the surface of the spinal cord on the lower back. These electrodes will be activated in the operating room and the degree of muscle activation assessed. The wire electrodes will then be removed. Small, disc electrodes will then be permanently implanted to stimulate expiratory muscles and restore cough. These electrodes are activated using an external control unit. | Procedure or surgery | Spinal Cord Stimulation |
| Expiratory Muscle StimulatorThe expiratory muscle stimulator consists of three small electrodes (metal discs) implanted over the surface of their spinal cords on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box. | Device | Spinal Cord Stimulation |
Primary outcome
The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes
Time frame: intra-operative
The effects of SCS with temporarily placed parallel wire leads and then with permanently implanted disc electrodes on airway pressure generation in each participant was evaluated in the operating room. The wire electrodes were temporarily placed (immediately prior to placement of disc electrodes as part of the current clinical trial) over the surface of the spinal cord on the lower back. These electrodes were activated, and the degree of expiratory muscle activation were assessed. The wire electrodes were then removed. Small, disc electrodes were then permanently implanted to stimulate expiratory muscles and restore cough. All measurements were repeated. Since SCS with the disc electrode leads, when applied in clinical trials, resulted in airway pressure generation that approximated pressures generated with a normal maximum cough, airway pressure generation achieved during SCS with these leads served as our gold standard to which all comparisons were made.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16543552DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Spinal cord stimulation: a new method to produce an effective cough in patients with spinal cord injury. Am J Respir Crit Care Med. 2006 Jun 15;173(12):1386-9. doi: 10.1164/rccm.200601-097CR. Epub 2006 Mar 16.
- Results publication: PubMed 19406289DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-sponsored clinical trial. Part I: methodology and effectiveness of expiratory muscle activation. Arch Phys Med Rehabil. 2009 May;90(5):717-25. doi: 10.1016/j.apmr.2008.11.013.
- Results publication: PubMed 19406290DiMarco AF, Kowalski KE, Geertman RT, Hromyak DR, Frost FS, Creasey GH, Nemunaitis GA. Lower thoracic spinal cord stimulation to restore cough in patients with spinal cord injury: results of a National Institutes of Health-Sponsored clinical trial. Part II: clinical outcomes. Arch Phys Med Rehabil. 2009 May;90(5):726-32. doi: 10.1016/j.apmr.2008.11.014.
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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
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 Spinal Cord Stimulation and Expiratory Muscle Stimulator in people with Spinal Cord Injuries and Spinal Cord Diseases, 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 2 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 14 Apr 2020. 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?
Yes. Results are posted in the registry (first posted 14 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Effects of Electrical Spinal Cord Stimulation (SCS) on Airway Pressure Generation While Using Temporarily Placed Parallel Wire Leads and Implanted Disc Electrodes (time frame: intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995215, which also lists 3 linked publications.
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 14 Apr 2020; AzTrials last refreshed its copy on 26 Oct 2026.