Spinal Stimulation + FES-Assisted Cough Training in SCI

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injuries

In brief

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.

Key facts

Study ID

NCT07683780

Run by

Milap Sandhu

People needed

60

Starts

2026-06-15

Expected to finish

2030-01-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shirley Ryan AbilityLab — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.