Spinal stimulation may restore cough power after paralysis
NCT ID NCT07683780
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This study tests whether combining spinal cord stimulation with electrical muscle stimulation can improve cough strength in people who recently had a spinal cord injury. Participants will receive either real or sham stimulation during cough training sessions over several weeks. The goal is to see if this approach helps them cough more forcefully and coordinate their breathing muscles better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous spinal cord stimulation and functional electrical stimulation
- What this could lead to
- If effective, this approach could help people with spinal cord injury cough more forcefully, reducing the risk of lung infections and improving breathing muscle coordination.
- What could go wrong
- This is an early-stage trial with a small number of participants, so results may not apply widely. The stimulation may cause discomfort or muscle twitching, and the cough improvement may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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: 1. 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 2. TSCS: Severe osteoporosis 3. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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