Spinal Cord InjuriesNCT03998527
Non-Invasive Spinal Cord Stimulation After Injury
A study testing Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) in people with Spinal Cord Injuries, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2018to 31 Dec 2029
- 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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of enrollment;
- Stable medical condition;
- Non-progressive SCI T5 or above;
- Sustained SCI at least 12 months prior to enrollment;
- At least a 15% deficit in pulmonary function outcomes (FVC or FEV1) as was detected by screening spirometry
- At least 21 years of age at the time of enrollment.
- FVC and FEV1 values 80% of predicted or above indicating healthy pulmonary function by screening spirometry.
Who cannot join
- Untreated musculoskeletal dysfunction;
- Unhealed fracture;
- Untreated contracture or pressure sore;
- Ventilator dependence;
- Untreated depression, psychiatric disorder, or ongoing drug abuse;
- Major pulmonary or cardiovascular disease;
Show all 13Show fewer
- Major esophageal or gastrointestinal disease;
- Endocrine disorder, malignancy, marked obesity, deep vein thrombosis, or HIV/AIDS related illness;
- Secondary causes of orthostatic hypotension (anemia, hypervolemia, endocrine, or neurological);
- Pregnancy by self-report.
- All Non-Disabled research participants, irrespective of gender, will be selected based on the following:
- History of respiratory disease by self-report,
- History of cardiovascular disease by self-report.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frazier Rehabilitation and Neuroscience Institute
Louisville, Kentucky, 40202
About this study
Official title: Non-Invasive Spinal Cord Stimulation and Respiratory Plasticity
The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function.
Read the detailed description
Study Aim 1. This study is aimed to evaluate the effects of non-invasive transcutaneous electrical spinal-cord stimulation (TcESCS) applied below the neurological level of Spinal Cord Injury (SCI) on respiratory, upper extremity, and trunk functional and motor control properties and identify their underlying physiological mechanisms. Evaluation of the mechanisms of respiratory and motor control modulations evoked by the TcESCS will have important implications for the development of specific therapeutic strategies to fight complications of SCI. The objective of Aim 1 is to investigate whether TcESCS can significantly increase activation of motor networks. This work will be done by electrophysiological characterization of respiratory and other motor responses as assessed at rest and in response to the respiratory and other challenges in SCI individuals. Changes in functional measures will be assessed when the TcESCS device is turned "off" and "on". To evaluate "dose-dependent" effects, changes in surface electromyographic (sEMG) magnitude and muscle co-activation will be assessed when stimulation parameters and location are changed during respiratory efforts and motor tasks. The extent to which the stimulation is associated with the largest change in respiratory and sEMG parameters will be implemented as a strategy to be used during stimulation in combination with Respiratory Training (RT), Arm Training (AT), and Trunk Training (TT). To attain the objective of this aim, we will test the working hypothesis that TcESCS excites specific motor networks leading to amplified motor responses. We will test this hypothesis by applying TcESCS during our original approach of the Respiratory Motor Control Assessment (RMCA) and other sEMG-based assessments with kinematics to characterize respiratory, arm, and trunk motor function. During these assessments, beat-to-beat Blood Pressure/ Heart Rate (BP/HR), and respiratory rate will be recorded to evaluate respiratory-cardiovascular responses. The rationale for this aim is that successful completion of the proposed research will contribute fundamental elements to our basic knowledge, without which the therapeutic value of TcESCS cannot be understood. The acquisition of such knowledge is critical to the development of specific rehabilitative strategies. When the proposed studies for Aim 1 have been completed, we expect that motor and inter-related characteristics affected by TcESCS in patients with SCI will be established. Such findings would be important because it will allow us, for the first time, to evaluate the ability of non-invasive spinal cord stimulation to enhance the decreased state of spinal network activity thus demonstrating the potential for rehabilitation.
Study Aim 2. The goal is to evaluate the effectiveness and therapeutic mechanisms of the TcESCS combined with task-specific (Respiratory Training) and non-task-specific (Arm Training and Trunk Training) interventions for breathing. Identification of the physiological effects of potential rehabilitative approaches will have important implications for the development of specific therapeutic strategies. The objective of Aim 2 is to investigate the therapeutic effects of RT regimen in combination with TcESCS. This work will be done by using methods outlined in Aim 1 and additional clinical measures all assessed before training, and repeatedly during follow-up period. Working hypothesis that compare to RT alone and TcESCS alone, RT assisted by TcESCS leads to enhanced use-dependent plasticity of respiratory motor networks, leading the functional recovery will be tested by using the approach of detecting changes in respiratory and other motor control outcome measures in response to stimulation and training. The rationale for this aim is that successful completion of the proposed research will advance the field by providing new avenues for the application of activity-based therapy accompanied by the spinal cord stimulation. When the proposed studies for Aim 2 have been completed, it is expected that the rehabilitative capacity of RT with TcESCS will be determined. Such results are important, because, for the first time, identified therapeutic mechanisms of TcESCS will provide evidence that this intervention can enhance the effects of activity-based therapy in participants with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)
- Keywords
- Respiration, Motor control
- Medical subject headings
- Spinal Cord Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)Device
Also called Non-invasive spinal cord stimulation
TcESCS is a non-invasive DC battery powered device. Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels. Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team. Every research participant will be slowly acclimated to stimulation. Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab. During the stimulation training sessions, we will monitor blood pressure regularly throughout the session.
| Study group | Role | What they receive |
|---|---|---|
| Non-Disabled (ND) and Spinal Cord Injured (SCI) controls | Experimental | The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention. The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS. The investigators will decide which stimulation type should be used for the post-mapping assessments. Receives: Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) |
| Spinal Cord Injured (SCI) intervention groups | Experimental | The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT. Receives: Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive respiratory electromyography
Respiratory muscle activity evaluated using vector analysis outcome measure.
Measured: Through study completion, an average of 1 year.
Spirometry
Respiratory activity evaluated using airflow outcome measure.
Measured: Through study completion, an average of 1 year.
Maximum airway pressure
Respiratory activity evaluated using airway pressure measurement.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (7)
Functional Neurophysiological Assessment (FNPA)
The FNPA assesses the motor capacity and control of the upper and lower extremities and trunk .
Measured: Through study completion, an average of 1 year.
Multisegmental Motor Response (MMR)
MMRs in response to non-invasive stimulation of the dorsal spinal cord assessed electromyographically
Measured: Through study completion, an average of 1 year.
Transcranial Magnetic Stimulation (TMS)
TMS of the cortex to assess the integrity of the descending corticospinal tracts
Measured: Through study completion, an average of 1 year.
Aerobic Endurance Test (VO2Peak)
Oxygen consumption during exercise
Measured: Through study completion, an average of 1 year.
Spinal Cord Independence Measure (SCIM)
Questionnaire to assess Self-Care and Mobility
Measured: Through study completion, an average of 1 year.
The Craig Handicap Assessment & Reporting Technique (CHART)
Questionnaire to measure the level of handicap in a community setting: physical independence, mobility, occupation, social integration, and economic self-sufficiency
Measured: Through study completion, an average of 1 year.
Beat-by-beat arterial blood pressure
Non-invasive blood pressure monitoring
Measured: During assessments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start17 May 2018
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- 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
- NCT03998527
- Sponsor's protocol ID
- 17.1279
- Status last verified
- Mar 2026
- First submitted
- 20 Jun 2019
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
PubMed 26205686
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
- Non-Invasive Spinal Cord Stimulation and Respiratory Plasticity
- ClinicalTrials.gov ID
- NCT03998527
- Acronym / sponsor ID
- 17.1279
- Conditions
- Spinal Cord Injuries
- Keywords
- Respiration, Motor control
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 17 May 2018 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 26 Jun 2019 (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.
The goal of this study is to assess the function of the lungs and the muscles are used to breathe after individuals receive respiratory training, spinal cord stimulation, a combination of respiratory training and stimulation, a combination of arm training and stimulation, or a combination of trunk training and stimulation. The respiratory, arm, and trunk training combined with the spinal stimulation interventions are being used to activate the spinal cord below the level of injury. Investigators will be looking for changes in the function of the lungs and trunk muscles before, during, and after these task-specific and non-task-specific interventions for breathing to determine which one has the greatest effect. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired lung, arm, and trunk function.
Detailed description
Study Aim 1. This study is aimed to evaluate the effects of non-invasive transcutaneous electrical spinal-cord stimulation (TcESCS) applied below the neurological level of Spinal Cord Injury (SCI) on respiratory, upper extremity, and trunk functional and motor control properties and identify their underlying physiological mechanisms. Evaluation of the mechanisms of respiratory and motor control modulations evoked by the TcESCS will have important implications for the development of specific therapeutic strategies to fight complications of SCI. The objective of Aim 1 is to investigate whether TcESCS can significantly increase activation of motor networks. This work will be done by electrophysiological characterization of respiratory and other motor responses as assessed at rest and in response to the respiratory and other challenges in SCI individuals. Changes in functional measures will be assessed when the TcESCS device is turned "off" and "on". To evaluate "dose-dependent" effects, changes in surface electromyographic (sEMG) magnitude and muscle co-activation will be assessed when stimulation parameters and location are changed during respiratory efforts and motor tasks. The extent to which the stimulation is associated with the largest change in respiratory and sEMG parameters will be implemented as a strategy to be used during stimulation in combination with Respiratory Training (RT), Arm Training (AT), and Trunk Training (TT). To attain the objective of this aim, we will test the working hypothesis that TcESCS excites specific motor networks leading to amplified motor responses. We will test this hypothesis by applying TcESCS during our original approach of the Respiratory Motor Control Assessment (RMCA) and other sEMG-based assessments with kinematics to characterize respiratory, arm, and trunk motor function. During these assessments, beat-to-beat Blood Pressure/ Heart Rate (BP/HR), and respiratory rate will be recorded to evaluate respiratory-cardiovascular responses. The rationale for this aim is that successful completion of the proposed research will contribute fundamental elements to our basic knowledge, without which the therapeutic value of TcESCS cannot be understood. The acquisition of such knowledge is critical to the development of specific rehabilitative strategies. When the proposed studies for Aim 1 have been completed, we expect that motor and inter-related characteristics affected by TcESCS in patients with SCI will be established. Such findings would be important because it will allow us, for the first time, to evaluate the ability of non-invasive spinal cord stimulation to enhance the decreased state of spinal network activity thus demonstrating the potential for rehabilitation.
Study Aim 2. The goal is to evaluate the effectiveness and therapeutic mechanisms of the TcESCS combined with task-specific (Respiratory Training) and non-task-specific (Arm Training and Trunk Training) interventions for breathing. Identification of the physiological effects of potential rehabilitative approaches will have important implications for the development of specific therapeutic strategies. The objective of Aim 2 is to investigate the therapeutic effects of RT regimen in combination with TcESCS. This work will be done by using methods outlined in Aim 1 and additional clinical measures all assessed before training, and repeatedly during follow-up period. Working hypothesis that compare to RT alone and TcESCS alone, RT assisted by TcESCS leads to enhanced use-dependent plasticity of respiratory motor networks, leading the functional recovery will be tested by using the approach of detecting changes in respiratory and other motor control outcome measures in response to stimulation and training. The rationale for this aim is that successful completion of the proposed research will advance the field by providing new avenues for the application of activity-based therapy accompanied by the spinal cord stimulation. When the proposed studies for Aim 2 have been completed, it is expected that the rehabilitative capacity of RT with TcESCS will be determined. Such results are important, because, for the first time, identified therapeutic mechanisms of TcESCS will provide evidence that this intervention can enhance the effects of activity-based therapy in participants with SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Disabled (ND) and Spinal Cord Injured (SCI) controls | Experimental | Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)The ND Control group (n=6) and SCI Control group (n=6) will be used to assess related values as acute effects of transcutaneous electrical spinal cord stimulation (TcESCS) itself and will not receive any training intervention. The ND group will receive baseline assessments, then up to 12 (4-Respiratory function, 4-Arm function, and 4-Trunk function) TcESCS mapping experiments, followed by repeating the assessments in the presence of TcESCS. The investigators will decide which stimulation type should be used for the post-mapping assessments. |
| Spinal Cord Injured (SCI) intervention groups | Experimental | Device: Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)The respiratory training (RT) group (n=6) will receive the respiratory training intervention only); the transcutaneous electrical spinal cord stimulation (TcESCS) group (n=6) will receive transcutaneous spinal cord stimulation only; TcESCS + RT group (n=6) will receive TcESCS combined with RT; TcESCS + Arm Training (AT) group (n=6) will receive TcESCS combined with AT; and TcESCS + Trunk Training (TT) group (n=6) will receive TcESCS combined with TT. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years of age at the time of enrollment;
- Stable medical condition;
- Non-progressive SCI T5 or above;
- Sustained SCI at least 12 months prior to enrollment;
- At least a 15% deficit in pulmonary function outcomes (FVC or FEV1) as was detected by screening spirometry
Key exclusion criteria (13 listed)
- Untreated musculoskeletal dysfunction;
- Unhealed fracture;
- Untreated contracture or pressure sore;
- Ventilator dependence;
- Untreated depression, psychiatric disorder, or ongoing drug abuse;
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 |
|---|---|---|
| Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)Also: Non-invasive spinal cord stimulationTcESCS is a non-invasive DC battery powered device. Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels. Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team. Every research participant will be slowly acclimated to stimulation. Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab. During the stimulation training sessions, we will monitor blood pressure regularly throughout the session. | Device | Non-Disabled (ND) and Spinal Cord Injured (SCI) controls, Spinal Cord Injured (SCI) intervention groups |
Primary outcome
Non-invasive respiratory electromyography
Time frame: Through study completion, an average of 1 year.
Respiratory muscle activity evaluated using vector analysis outcome measure.
Spirometry
Time frame: Through study completion, an average of 1 year.
Respiratory activity evaluated using airflow outcome measure.
Maximum airway pressure
Time frame: Through study completion, an average of 1 year.
Respiratory activity evaluated using airway pressure measurement.
7 secondary outcomes
Functional Neurophysiological Assessment (FNPA)
Time frame: Through study completion, an average of 1 year.
Multisegmental Motor Response (MMR)
Time frame: Through study completion, an average of 1 year.
Transcranial Magnetic Stimulation (TMS)
Time frame: Through study completion, an average of 1 year.
Aerobic Endurance Test (VO2Peak)
Time frame: Through study completion, an average of 1 year.
Spinal Cord Independence Measure (SCIM)
Time frame: Through study completion, an average of 1 year.
The Craig Handicap Assessment & Reporting Technique (CHART)
Time frame: Through study completion, an average of 1 year.
Beat-by-beat arterial blood pressure
Time frame: During assessments.
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.
- Background: PubMed 26205686Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
- 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. This study is not recruiting at the moment.
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 Transcutaneous Electrical Spinal Cord Stimulation (TcESCS) in people with Spinal Cord Injuries, 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 7 inclusion and 13 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: under way, not looking for participants, 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?
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?
Non-invasive respiratory electromyography (time frame: Through study completion, an average of 1 year.). The study lists 3 primary outcomes in all. 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 NCT03998527, which also lists 1 linked publication.
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.