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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcutaneous spinal cord stimulation | Experimental | Individuals with motor complete cervicothoracic spinal cord injury admitted to tertiary inpatient rehabilitation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous spinal cord stimulation | Device | Individuals 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start to end of treatment at 2 weeks |
| 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) | From start to end of treatment at 2 weeks |
| 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 | From start to end of each stimulation treatment |
| 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 | From start to end of each stimulation treatment |
| Pain levels | Participants will be asked to rate their average pain during each session of stimulation (numerical rating scale from 0-10, 10 being maximum pain) | At the end of each stimulation session |
| Bladder continence | Participants will be asked to document bladder continence immediately before and after finishing 10 days of stimulation, using the Revised Urinary Incontinence scale. This scale is a validated 5 question tool to evaluate urinary continence, with the score ranging from 0 to 15, with higher scores indicative of more distressing incontinence. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week before the stimulation protocol to two weeks after the stimulation protocol |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexander J Whelan, MD | Contact | 9024731409 | alexj.whelan@nshealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Whelan, MD | NSHA | Principal Investigator |
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| ID | Term |
|---|---|
| D055496 | Neurogenic Bowel |
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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all patients will be treated with the transcutaneous spinal cord stimulation to see if it affects bowel movements
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| prior to the start of stimulation period and at the end of stimulation period |
| Skin health | The incidence of pressure injuries with visualization using NPIAP staging, with documentation of size (width and length) will be documented. The skin overlying the cathodes and anodes will be visually inspected before and after each stimulation session. | At the start and end of each stimulation session |
| 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. | Before, immediately after and two weeks after the stimulation protocol |
| 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. | Before, immediately after and two weeks after the stimulation protocol |
| D004066 | Digestive System Diseases |
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |