The primary goals of this pilot trial are to understand the feasibility and safety of thoracolumbar transcutaneous spinal cord stimulation for neurogenic bowel management in individuals with new onset, traumatic, cervicothoracic spinal cord injury admitted to inpatient rehabilitation.
The secondary goal is to understand the clinical impact of thoracolumbar spinal cord stimulation on bowel function.
Study participants will receive a 10-day course of transcutaneous spinal cord stimulation at T10-T11 and T12-L1. Each daily treatment will consist of 30 minutes of stimulation.
Feasibility will be evaluated by documenting how many stimulation sessions were attended per participant, and the average duration of stimulation provided per session (with a maximum value of 30 minutes). It is believed that transcutaneous spinal cord stimulation will be feasible to deliver for participants receiving inpatient rehabilitation.
Safety will be evaluated by documenting hemodynamic parameters (heart and blood pressure) and pain levels during each stimulation session. The skin will be evaluated after treatment to ensure no pressure injuries. Participants will be asked to document bladder continence before and after the two-week stimulation protocol, to understand if there are any changes on bladder function, given similar nerve root innervation as bowel function. Investigators expect that transcutaneous spinal cord stimulation will be safe, with minimal adverse effects on heart, blood pressure, skin integrity, pain levels and bladder continence.
The impact on bowel function will be evaluated by completing a bowel diary documenting the time spent on bowel care per day per participant. Participants will also rate their satisfaction with bowel care before, immediately after and two weeks after the 10-day stimulation protocol. Peak cough flow will be collected before, immediately after and two weeks after the 10-day stimulation protocol, as surrogate measures of abdominal strength, which is important for timely bowel evacuation. It is believed that transcutaneous spinal cord stimulation will reduce time spent on bowel care and improve participant-reported satisfaction with bowel care, and it will be associated with improvements in peak cough flow.
Individual must have a T10 and above AIS A-B traumatic spinal cord injury
Individual must be 16 years or older
They must be willing to comply with the study procedure and be medically stable
They must be at least 3 months since their injury, to minimize the chances that they are in spinal shock, which may influence the impact of TSCS as the peripheral nerves may be less excitable)
Individuals with a pacemarker, cochlear implant, baclofen pump or other implantable device that may be affected by electrical stimulation.
Individuals with epilepsy
Individuals with open wounds at stimulation sites
Individuals with implanted metal in the trunk and spinal cord at the cathode pad application sites (i.e. T10 to L2)
Single group
Transcutaneous spinal cord stimulation
DeviceIndividuals will receive a 10-day course of daily, 30-minute sessions of transcutaneous spinal cord stimulation to the thoracolumbar spine cord using the Chattanooga Mobile 2 Stim Device. These sessions will be conducted in the morning before bowel care and therapy. Cathode pads will be placed between the T10 and T11 spinous processes and the T12 and L1 spinous processes. Anode pads will be placed over the iliac crests. Stimulation will consist of 1 millisecond duration, biphasic pulses, at 30 Hertz frequency. The intensity of the current, will be adjusted to be suprasensory and sub-motor, and no more than 140 milli-amperes.
Feasibility: number of stimulation sessions attended
Feasibility will be calculated as the number of sessions (out of 10) when participants were able to engage in transcutaneous spinal cord stimulation. The reason for missed sessions will be recorded.
Feasibility: duration of stimulation tolerated per session
Feasibility will be calculated as the average duration of transcutaneous spinal cord stimulation tolerated by participants each session (i.e. the maximum value is 30 minutes, which is a full session of stimulation)
Blood Pressure
Systolic and diastolic blood pressure will be taken immediately before each stimulation session, every 10 minutes during the 30-minute session, and after completion of each session
Heart rate
Heart rate will be taken immediately before each stimulation session, every 10 minutes during the 30-minute session, and after completion of each session
Time spent on bowel care
Nurses assigned to patient care will complete a bowel diary, which is part of clinical care. This will document the time spent on bowel care, starting one week before TSCS and extending to two weeks after TSCS. The time spent will be calculated from the time of suppository insertion/rectal touch until clean-up by nursing.
Satisfaction with Bowel Care
We will have participants rate their satisfaction with bowel emptying before, immediately after and two weeks after TSCS. This will be completed using a numerical rating scale from 0-10, where 0 = no satisfaction and 10 = complete satisfaction.
Peak cough flow
We will collect the peak cough before, immediately after the stimulation protocol and 2 weeks after the stimulation protocol. The peak cough flow will be the average of three attempts at each time point.
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