Spinal Cord InjuriesNCT05178056
Spinal Cord Stimulation and Respiration After Injury
A study testing Spinal Cord Epidural Stimulation and Respiratory Training in people with Spinal Cord Injuries and Spinal Cord Stimulation, run by University of Louisville at 1 site in United States.
Trial summary
Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Spinal Cord Stimulation, Breathing Exercises
- What is being tested?
- Spinal Cord Epidural Stimulation and Respiratory Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2021to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Stable medical condition
- Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
- Sustained SCI at least 24 months prior to entering the study
- At least 15%-deficit in pulmonary function outcomes
Who cannot join
- Painful musculo-skeletal dysfunction
- Unhealed fracture
- Contracture
- Pressure sore
- Urinary tract infection that might interfere with respiratory training
- Clinically significant depression
Show all 20Show fewer
- Psychiatric disorders
- Ongoing drug abuse;
- Major cardiovascular disease
- Major pulmonary disease
- Ventilator dependence
- Major endocrine disorders
- Malignancy
- Marked obesity
- Deep vein thrombosis
- HIV/AIDS related illness
- Secondary causes of respiratory dysfunction
- Major gastrointestinal problems
- Other major medical illness contraindicated for respiratory training
- Pregnantcy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, 40202
Adrea Willhite, MS, 502-582-8675, andrea.willhite@louisville.edu
Alexander V Ovechkin, MD, PhD
About this study
Official title: Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury
Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
Read the detailed description
Spinal cord injury (SCI) is commonly associated with motor control deficits. When injury alters the control of trunk muscles, respiratory function is compromised leading to respiratory complications (including COVID19-related), one of the primary causes of morbidity and mortality in patients with chronic SCI. However, none of the respiratory rehabilitative modalities for this population have yet been proven to be clinically effective.
Previous work demonstrated that respiratory motor function can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. It have been found that these improvements are associated with respiratory motor and autonomic activity-based plasticity. However, due to low excitability of spinal networks below the injury, the effectiveness of this intervention is limited to the levels of functional capacity preserved after injury.
Epidural Stimulation (scES) can activate spinal networks below level of the spinal cord lesion. It was demonstrated that tonic scES at the lumbar level in individuals with SCI lead to voltage-dependent changes in breathing pattern and enhanced voluntary respiratory muscle activation below the injury level. Preliminary data collected for this proposal indicate that spinal cord stimulation can enhance the adaptive plasticity and provide amplified therapeutic effects when it is combined with respiratory training.
The objective of this study is to investigate the mechanisms of respiratory functional and respiratory motor responses to the scES as an important step toward the long-term goal of developing effective evidence-based rehabilitation strategies for patients with SCI. The central hypothesis is that scES raises the excitability of motor networks for respiration resulting in amplified use-dependent neural plasticity in response to the respiratory training. The rationale for the proposed study is to justify the development of a new direction in respiratory rehabilitation by using respiratory training in combination with electrical spinal cord stimulation.
The central hypothesis will be tested by pursuing the following two specific aims:
Specific Aim 1: Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties.
Hypothesize is that the scES increases spinal motor network excitability leading to increased respiratory functional outcomes due to enhanced activation of neural networks specific for respiration. A comparative approach focusing on clinical and electrophysiological characterizations of respiratory functional and motor control responses in the presence or absence of scES in individuals with high-level chronic SCI will be used. Respiratory motor control will be characterized by using pulmonary function test, electromyography and recordings of trunk kinematics assessed during respiratory efforts. During these assessments, beat-to-beat blood pressure and heart rate / respiratory rate variability will be assessed to evaluate respiratory-cardiovascular interactions.
Specific Aim 2: Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
Hypothesis is that specifically configured scES combined with respiratory training allows enhanced use-dependent neural plasticity for respiration. This hypotheses will be confirmed if the respiratory training combined with scES results in significantly improved functional outcomes when compared to the measures obtained from either scES-only or respiratory training-only groups. The physiological characterization of respiratory functional and motor control responses in these groups will be used to identify specific therapeutic effects. This work will be done by using methods outlined in Aim 1 and additional clinical measures all assessed before/after stimulation and/or training and during the follow-up period.
This randomized, controlled clinical trial will evaluate the effects of the scES approach to target respiratory neural networks and will test the rehabilitative capacity of respiratory activity-based training in combination with spinal cord stimulation applied epidurally. Such results are expected to have an important positive impact, because, for the first time, identified effects of this strategy will provide evidence that respiratory function can be effectively restored in patients with severe chronic SCI.
- Being tested
- Spinal Cord Epidural Stimulation, Respiratory Training
- Keywords
- Epidural Spinal Cord Stimulation, Respiratory Training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Epidural StimulationDevice
Spinal Cord Epidural Stimulation (scES) will be administered by a multi-electrode array (5-6-5 SpecifyTM electrode, MEDTRONIC, Minneapolis, MN, USA) previously implanted in the epidural space over the dorsum of the spinal cord.
Respiratory TrainingOther
Standard threshold Positive Expiratory Pressure Device and standard threshold Inspiratory Muscle Trainer (Respironics Inc., Cedar Grove, NJ) assembled together will be used for respiratory training sessions to complete eighty 45-minute sessions during 16 weeks. The participants will be instructed to perform inspiratory and expiratory efforts against a pressure treshold load.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Training | Active comparator | Research subjects with no implanted stimulator undergoing RT intervention. Receives: Other: Respiratory Training |
| Spinal Cord Stimulation | Active comparator | Research subjects with implanted stimulator undergoing stimulation intervention. Receives: Device: Spinal Cord Epidural Stimulation |
| Spinal Cord Stimulation and Respiratory Training | Experimental | Research subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training. Receives: Device: Spinal Cord Epidural Stimulation; Other: Respiratory Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Expiratory Pressure (PEmax)
Standard Spirometry measurement.
Measured: Through study completion, an average of 1 year.
Change in Surface electromyography (sEMG) Magnitude (Mag)
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Measured: Through study completion, an average of 1 year.
Change in Surface electromyography (sEMG) Similarity Index (SI)
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Measured: Through study completion, an average of 1 year.
Change in Maximum Inspiratory Pressure (PImax)
Standard Spirometry measurement.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Change in Forced Vital Capacity (FVC)
Standard Spirometry measurement.
Measured: Through study completion, an average of 1 year.
Change in Forced Expiratory Volume in 1 second (FEV1)
Standard Spirometry measurement.
Measured: Through study completion, an average of 1 year.
Change in Baroreflex sensitivity (BRS)
Measure of the beat-to-beat blood pressure and heart rate variability assessed during a Valsalva maneuver and maximum respiratory effort.
Measured: Through study completion, an average of 1 year.
Change in Baroreflex Effectiveness Index (BEI)
Measure of the beat-to-beat blood pressure and heart rate variability assessed during a Valsalva maneuver and maximum respiratory effort.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start31 Dec 2021
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Dec 2030 (estimated)
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.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Our goal is to evaluate the effects of the individually optimized spinal cord Epidural Stimulation (scES) (Aim 1) and to define the efficacy of scES combined with Respiratory Training (RT) (Aim 2) in individuals with Spinal Cord Injury (SCI). Thirty participants with SCI will be recruited, twenty of them will have scES implanted. After screening and recruitment, primary and secondary outcome measurements will be obtained in the Lab at the following time points: 1) Pre intervention, after 30-days without any stimulation and/or intervention, 2) Post mapping, (participants with scES, n=20), 3) Post Session #40 (after 8 weeks of intervention) and 4) Post Session #80 (after 16 weeks of intervention), and 5) Post 16-weeks Follow-up Period. In total, it is anticipated that 5 measurements will be obtained for each participant with implanted scES and 4 measurements for participants without scES.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Alexander V Ovechkin, MD, PhD, University of Louisville
- Investigators
- Alexander Ovechkin, MD, PhD, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178056
- Sponsor's protocol ID
- 21.0564/17.1024
- Other IDs
- R01HL150581
- Status last verified
- Mar 2026
- First submitted
- 1 Dec 2021
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Spinal Cord Stimulation and Respiratory Motor Function After Injury
- ClinicalTrials.gov ID
- NCT05178056
- Acronym / sponsor ID
- 21.0564/17.1024
- Keywords
- Epidural Spinal Cord Stimulation, Respiratory Training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 5 Jan 2022 (actual)
- 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.
Respiratory motor control deficit is the leading cause of morbidity and mortality in patients with spinal cord injury. The long-term goal of this NIH-funded study is to develop a rehabilitation strategy for respiration in patients with spinal cord injury as a standard of care. Respiratory function in patients with chronic spinal cord injury can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. However, the effectiveness of this intervention is limited by the levels of functional capacity preserved below the neurological level of injury. Preliminary data obtained for this study demonstrate that electrical spinal cord stimulation applied epidurally at the lumbar level in combination with respiratory training can activate and re-organize spinal motor networks for respiration. This study is designed to investigate respiratory motor control-related responses to epidural spinal cord stimulation alone and in combination with respiratory training. By characterization of respiratory muscle activation patterns using surface electromyography in association with pulmonary functional and respiration-related cardiovascular measures, the investigators expect to determine the specific stimulation parameters needed to increase spinal excitability below level of injury to enhance responses to the input from supraspinal centers that remain after injury and to promote the neural plasticity driven by the respiratory training. This hypothesis will be tested by pursuing two Specific Aims: 1) Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties; and 2) Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
Detailed description
Spinal cord injury (SCI) is commonly associated with motor control deficits. When injury alters the control of trunk muscles, respiratory function is compromised leading to respiratory complications (including COVID19-related), one of the primary causes of morbidity and mortality in patients with chronic SCI. However, none of the respiratory rehabilitative modalities for this population have yet been proven to be clinically effective.
Previous work demonstrated that respiratory motor function can be improved by using inspiratory-expiratory pressure threshold respiratory training protocol. It have been found that these improvements are associated with respiratory motor and autonomic activity-based plasticity. However, due to low excitability of spinal networks below the injury, the effectiveness of this intervention is limited to the levels of functional capacity preserved after injury.
Epidural Stimulation (scES) can activate spinal networks below level of the spinal cord lesion. It was demonstrated that tonic scES at the lumbar level in individuals with SCI lead to voltage-dependent changes in breathing pattern and enhanced voluntary respiratory muscle activation below the injury level. Preliminary data collected for this proposal indicate that spinal cord stimulation can enhance the adaptive plasticity and provide amplified therapeutic effects when it is combined with respiratory training.
The objective of this study is to investigate the mechanisms of respiratory functional and respiratory motor responses to the scES as an important step toward the long-term goal of developing effective evidence-based rehabilitation strategies for patients with SCI. The central hypothesis is that scES raises the excitability of motor networks for respiration resulting in amplified use-dependent neural plasticity in response to the respiratory training. The rationale for the proposed study is to justify the development of a new direction in respiratory rehabilitation by using respiratory training in combination with electrical spinal cord stimulation.
The central hypothesis will be tested by pursuing the following two specific aims:
Specific Aim 1: Evaluate the acute effects of epidural spinal cord stimulation on respiratory functional and motor control properties.
Hypothesize is that the scES increases spinal motor network excitability leading to increased respiratory functional outcomes due to enhanced activation of neural networks specific for respiration. A comparative approach focusing on clinical and electrophysiological characterizations of respiratory functional and motor control responses in the presence or absence of scES in individuals with high-level chronic SCI will be used. Respiratory motor control will be characterized by using pulmonary function test, electromyography and recordings of trunk kinematics assessed during respiratory efforts. During these assessments, beat-to-beat blood pressure and heart rate / respiratory rate variability will be assessed to evaluate respiratory-cardiovascular interactions.
Specific Aim 2: Evaluate the effectiveness of epidural spinal cord stimulation combined with respiratory training.
Hypothesis is that specifically configured scES combined with respiratory training allows enhanced use-dependent neural plasticity for respiration. This hypotheses will be confirmed if the respiratory training combined with scES results in significantly improved functional outcomes when compared to the measures obtained from either scES-only or respiratory training-only groups. The physiological characterization of respiratory functional and motor control responses in these groups will be used to identify specific therapeutic effects. This work will be done by using methods outlined in Aim 1 and additional clinical measures all assessed before/after stimulation and/or training and during the follow-up period.
This randomized, controlled clinical trial will evaluate the effects of the scES approach to target respiratory neural networks and will test the rehabilitative capacity of respiratory activity-based training in combination with spinal cord stimulation applied epidurally. Such results are expected to have an important positive impact, because, for the first time, identified effects of this strategy will provide evidence that respiratory function can be effectively restored in patients with severe chronic SCI.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Our goal is to evaluate the effects of the individually optimized spinal cord Epidural Stimulation (scES) (Aim 1) and to define the efficacy of scES combined with Respiratory Training (RT) (Aim 2) in individuals with Spinal Cord Injury (SCI). Thirty participants with SCI will be recruited, twenty of them will have scES implanted. After screening and recruitment, primary and secondary outcome measurements will be obtained in the Lab at the following time points: 1) Pre intervention, after 30-days without any stimulation and/or intervention, 2) Post mapping, (participants with scES, n=20), 3) Post Session #40 (after 8 weeks of intervention) and 4) Post Session #80 (after 16 weeks of intervention), and 5) Post 16-weeks Follow-up Period. In total, it is anticipated that 5 measurements will be obtained for each participant with implanted scES and 4 measurements for participants without scES.
| Arm | Type | Receives |
|---|---|---|
| Respiratory Training | Active comparator | Other: Respiratory TrainingResearch subjects with no implanted stimulator undergoing RT intervention. |
| Spinal Cord Stimulation | Active comparator | Device: Spinal Cord Epidural StimulationResearch subjects with implanted stimulator undergoing stimulation intervention. |
| Spinal Cord Stimulation and Respiratory Training | Experimental | Device: Spinal Cord Epidural Stimulation, Other: Respiratory TrainingResearch subjects with implanted stimulator undergoing stimulation intervention in combination with respiratory training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Stable medical condition
- Non-progressive C3-T1 AIS A-C Spinal Cord Injury (SCI)
- Sustained SCI at least 24 months prior to entering the study
- At least 15%-deficit in pulmonary function outcomes
Key exclusion criteria (20 listed)
- Painful musculo-skeletal dysfunction
- Unhealed fracture
- Contracture
- Pressure sore
- Urinary tract infection that might interfere with respiratory training
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 Epidural StimulationSpinal Cord Epidural Stimulation (scES) will be administered by a multi-electrode array (5-6-5 SpecifyTM electrode, MEDTRONIC, Minneapolis, MN, USA) previously implanted in the epidural space over the dorsum of the spinal cord. | Device | Spinal Cord Stimulation, Spinal Cord Stimulation and Respiratory Training |
| Respiratory TrainingStandard threshold Positive Expiratory Pressure Device and standard threshold Inspiratory Muscle Trainer (Respironics Inc., Cedar Grove, NJ) assembled together will be used for respiratory training sessions to complete eighty 45-minute sessions during 16 weeks. The participants will be instructed to perform inspiratory and expiratory efforts against a pressure treshold load. | Other | Respiratory Training, Spinal Cord Stimulation and Respiratory Training |
Primary outcome
Change in Maximum Expiratory Pressure (PEmax)
Time frame: Through study completion, an average of 1 year.
Standard Spirometry measurement.
Change in Surface electromyography (sEMG) Magnitude (Mag)
Time frame: Through study completion, an average of 1 year.
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Change in Surface electromyography (sEMG) Similarity Index (SI)
Time frame: Through study completion, an average of 1 year.
Respiratory multi-muscle activation measures assessed using standard surface electromyography.
Change in Maximum Inspiratory Pressure (PImax)
Time frame: Through study completion, an average of 1 year.
Standard Spirometry measurement.
4 secondary outcomes
Change in Forced Vital Capacity (FVC)
Time frame: Through study completion, an average of 1 year.
Change in Forced Expiratory Volume in 1 second (FEV1)
Time frame: Through study completion, an average of 1 year.
Change in Baroreflex sensitivity (BRS)
Time frame: Through study completion, an average of 1 year.
Change in Baroreflex Effectiveness Index (BEI)
Time frame: Through study completion, an average of 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Alexander Ovechkin, MD, PhD principal investigator
University of Louisville
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 Epidural Stimulation and Respiratory Training in people with Spinal Cord Injuries and Spinal Cord Stimulation, run by University of Louisville 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 5 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: looking for participants now, as of the sponsor's last update on 13 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Ovechkin, MD, PhD (5025818675, avovec02@louisville.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum Expiratory Pressure (PEmax) (time frame: Through study completion, an average of 1 year.). The study lists 4 primary outcomes in all. 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 13 Mar 2026.