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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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.
Shirley Ryan AbilityLab
Chicago, Illinois, United States
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)
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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