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Spinal Stimulation + FES-Assisted Cough Training in SCI

This study is looking at whether a combination of transcutaneous spinal cord stimulation (tSCS) and functional electrical stimulation (FES)-assisted cough training can improve cough strength and coordination in people with recent spinal cord injuries. You might be able to join if you are 18-65 years old, currently in inpatient rehabilitation at Shirley Ryan AbilityLab, and had a traumatic spinal cord injury (C1-T1, AIS A-C) 14-60 days ago, with a baseline cough flow below 270 L/min. The study aims to see if participants receiving tSCS combined with FES-Cough show greater improvements in cough strength and timing compared to those receiving a sham (inactive) tSCS with FES-Cough. The study's status is currently unclear.

Study design
This interventional study plans to enroll 60 participants. It compares two groups: one receiving active tSCS with FES-Cough, and another receiving sham tSCS with FES-Cough.
What's involved
You would have 20 sessions of treatment, each lasting 30 minutes, 2 to 4 times per week for 4 to 6 weeks. Your cough strength and coordination will be measured at enrollment, during the intervention, and at a follow-up around 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your cough strength and coordination will be assessed up to approximately 10 weeks after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07683780

Spinal Stimulation + FES-Assisted Cough Training in SCI

Enrolling by Invitation
NAAges 18–65InterventionalTreatment
Milap Sandhu
~60 participants
Updated 2026-07-06 on ClinicalTrials.gov
What's tested:tSCS combined with FES-CoughSham tSCS + FES assisted cough

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Peak Cough Flow
Measured over From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
+1 more outcome measured

Conditions

Spinal Cord Injuries

Explore related trials

Spinal Cord Injury

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Milap Sandhu, PhD, PT · PRINCIPAL_INVESTIGATOR · Shirley Ryan AbilityLab

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Peak Cough FlowFrom 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 VolumeFrom 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.