Spinal Cord InjuriesNCT07683780
Spinal Stimulation + FES-Assisted Cough Training in SCI
A study testing tSCS combined with FES-Cough in people with Spinal Cord Injuries, run by Milap Sandhu at 1 site in United States.
Trial summary
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- tSCS combined with FES-Cough
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to Jan 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
- History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
- Between 14-60 days from date of injury at time of enrollment
- Baseline PCF below 270 L/min
- Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
- Medically cleared by the participants primary inpatient physiatry attending physician
Who cannot join
- Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
- Individuals with contraindications to the interventions of interest:
- TSCS and Abdominal FES: pacemaker, compromised skin integrity under site of stimulation, implanted defibrillators, deep brain stimulator(s), uncontrolled epilepsy or seizures, pregnancy, recent myocardial infarct, diaphragmatic pacer
- TSCS: Severe osteoporosis
- Abdominal FES: unhealed rib fracture, sternal precautions, recent pneumothorax, spine bracing impacting ability to place stimulation pads.
- Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
- Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.
Read the detailed description
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.
Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.
- Conditions
- Spinal Cord Injuries
- Being tested
- tSCS combined with FES-Cough, Sham tSCS + FES assisted cough
- Keywords
- Spinal Stimulation, Cough, Functional Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tSCS combined with FES-CoughOther
A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks.
tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch.
FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.
Sham tSCS + FES assisted coughOther
A clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response.
| Study group | Role | What they receive |
|---|---|---|
| Sham tSCS + FES-Assisted Cough | Sham comparator | In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain Receives: Other: Sham tSCS + FES assisted cough |
| tSCS + FES-Assisted Cough | Active comparator | This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously Receives: Other: tSCS combined with FES-Cough |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Cough Flow
Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device. The maximum number will be recorded.
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Cough Partial Expiratory Flow Volume
Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements. The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Secondary outcomes (4)
Maximum inspiratory pressure
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum inspiratory pressure (MIP)
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Changes in electromyography (EMG) of respiratory muscles
Assesses respiratory muscle activation during the cough. We will use surface EMG electrodes placed on various respiratory muscles on the abdomen and upper trunk to plot muscle activation during single and sequential cough epochs.
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Maximum expiratory pressure
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find maximum expiratory pressure (MEP)
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Forced expiratory volume
Assesses respiratory muscle strength by asking the participants to inhale or exhale quickly with their lips sealed around the mouthpiece of the training device to find forced expiratory volume in the first second (FEV1)
Measured: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start15 Jun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJan 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.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milap Sandhu
- Sponsor type
- University, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Responsible party
- Sponsor-investigator, Milap Sandhu, Shirley Ryan AbilityLab
- Investigators
- Milap Sandhu, PhD, PT, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07683780
- Sponsor's protocol ID
- STU00225588
- Other IDs
- 1529723
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon request, de-identified data may be shared by the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Transcutaneous Spinal Stimulation + FES-Assisted Cough Training in Acute SCI
- ClinicalTrials.gov ID
- NCT07683780
- Acronym / sponsor ID
- STU00225588
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Stimulation, Cough, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Milap SandhuUniversity, hospital or other
- Collaborators
- Shirley Ryan AbilityLab
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 6 Jul 2026 (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 overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) is an effective intervention to improve cough strength and coordination in individuals with acute/subacute SCI.
Detailed description
The overall objective of this proposal is to determine if transcutaneous spinal cord stimulation (tSCS) delivered concurrently with functional electrical stimulation (FES)-assisted cough training (FES-Cough) can synergistically improve cough strength and coordination in individuals with acute/subacute SCI. Aim 1: Determine the efficacy of tSCS combined with FES-Cough in individuals with acute/subacute SCI to improve cough strength and respiratory function. Spirometric values and respiratory pressures will be assessed as well as breathlessness and hypophonia after 20 sessions of active tSCS combined with FES-Cough vs. sham tSCS combined with FES-Cough administered over 4-6 weeks Aim 2: Analyze the effect of tSCS combined with FES-cough on cough coordination and sequencing through a detailed analysis of cough partial expiratory flow-volume (CPEFV) curves and respiratory muscle EMG before and after each of the interventions, including comparative analysis of EMG cough activity between individuals with neurologic injury and healthy control participants.
Th hypothesis is that participants receiving tSCS + FES-Cough will demonstrate significantly greater improvements in unstimulated peak cough flow, normalized cough phase timing, and improved flow-volume characteristics compared to the sham + FES-Cough group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham tSCS + FES-Assisted Cough | Sham comparator | Other: Sham tSCS + FES assisted coughIn this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain |
| tSCS + FES-Assisted Cough | Active comparator | Other: tSCS combined with FES-CoughThis group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Currently admitted for inpatient rehabilitation at Shirley Ryan AbilityLab
- History of traumatic spinal cord injury with Neurologic Level of Injury (NLI) C1-T1, and AIS A-C on admission exam
- Between 14-60 days from date of injury at time of enrollment
- Baseline PCF below 270 L/min
- Anatomical airway or tolerating occlusion of tracheostomy with either a one-way speaking valve or a cap for at least 60 minutes
Key exclusion criteria (7 listed)
- Individuals with pre-morbid chronic pulmonary conditions, day-time ventilator dependence, uncontrolled autonomic dysreflexia, moderate to severe traumatic brain injury, developmental delay, diagnosis of active cancer, or secondary progressive neurologic disorder
- Individuals with contraindications to the interventions of interest:
- Individuals with medical instability impacting the safety and feasibility of participation including the inability to tolerate sitting upright >45 degrees for 15 minutes, acute unresolved medical complications as determined by study physician to be exclusionary, transferred to higher level of medical care for ≥5 consecutive days or >14 days total during trial period, and those with halo spine bracing
- Individuals who are currently enrolled in another interventional research study are excluded from participating to eliminate potential influence of additional experimental interventions on study outcomes and to maintain standardization of study protocol
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 |
|---|---|---|
| tSCS combined with FES-CoughA clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response. | Other | tSCS + FES-Assisted Cough |
| Sham tSCS + FES assisted coughA clinician will don the electrodes on the participant for 20, 30 minute sessions 2 to 4 times per week for 4 to 6 weeks. tSCS will utilize multi-site stimulation at C3-C4 and T9-10, with simulation intensity being set for each electrode which produces a visible muscle twitch. The sham group will have intensity will be ramped up to sensation for 1 minute then ramped down and turned off FES will be set up by placing electode pads in the posterolateral positon on the trunk. Baseline stimulation parameters are 50Hz Frequency, 250-400μs pulse duration, altering monophasic waveform, amplitude dependent on participant response. | Other | Sham tSCS + FES-Assisted Cough |
Primary outcome
Peak Cough Flow
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses functional cough strength via a digital peak flow by asking the participant to cough three times into the device. The maximum number will be recorded.
Cough Partial Expiratory Flow Volume
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Assesses the effectiveness of a cough by plotting airflow during the cough against lung volume, and allowing all phases of cough to be visualized and calculate spirometric measurements. The participant will be fit with a facemask that will go over their nose and mouth, and then be asked to perform a series of single coughs and sequential coughs.
4 secondary outcomes
Maximum inspiratory pressure
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Changes in electromyography (EMG) of respiratory muscles
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Maximum expiratory pressure
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Forced expiratory volume
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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 6 Jul 2026.
- Individual participant dataSharing planned: Yes. Upon request, de-identified data may be shared by the principal investigator
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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.
Milap Sandhu, PhD, PT principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tSCS combined with FES-Cough in people with Spinal Cord Injuries, run by Milap Sandhu at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 6 Jul 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. Some participants in this study may receive a placebo. 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?
Peak Cough Flow (time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks). The study lists 2 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 6 Jul 2026.