An interventional study of tSCS combined with FES-Cough and Sham tSCS + FES assisted cough in Spinal Cord Injuries, sponsored by Milap Sandhu. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Milap Sandhu · Not applicable, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 60 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
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Exclusion Criteria:
Individuals with to the interventions of interest:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, the tSCS spinal stimulation will be sham, providing no additional electrical input, while the FES assisted cough intervention will remain
Other: Sham tSCS + FES assisted cough
This group will receive the combination of tSCS spinal stimulation and FES assisted cough simultaneously
Other: tSCS combined with FES-Cough
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.
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.
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.
Time frame: 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.
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: From time of enrollment, through intervention, up to follow up assessment approximately 10 weeks
Plan to share: Yes — Upon request, de-identified data may be shared by the principal investigator
Supporting information: Study protocol, Informed consent form
Time frame: Until 3 years following conclusion of study procedures
Access criteria: Principal investigator will retain this access and distribute upon request
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Milap Sandhu