Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury

Not Applicable

Not yet recruiting

• Conditions: Neurogenic Bowel; Spinal Cord Injuries (SCI)

• Registration Number: NCT06801431
• Lead Sponsor: Nova Scotia Health Authority

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-24
• Last Update Submitted: 2025-01-24
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30
• Study Start: 2025-09-01
• Primary Completion: 2027-09-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

1. Individual must have a T10 and above AIS A-B traumatic spinal cord injury
2. Individual must be 16 years or older
3. They must be willing to comply with the study procedure and be medically stable
4. 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)
5. There must not be any changes to their bowel medications or bowel regimen in the week leading up to the intervention, to minimize any confounding effect on bowel habits
6. They must have bowel care either daily or q2 days

Exclusion Criteria

1. Individuals with a pacemarker, cochlear implant, baclofen pump or other implantable device that may be affected by electrical stimulation.
2. Individuals with epilepsy
3. Individuals with open wounds at stimulation sites
4. Individuals with implanted metal in the trunk and spinal cord at the cathode pad application sites (i.e. T10 to L2)
5. Individuals with a severe acute medical issue that is felt to affect participation at the discretion of the research team, including individuals with uncontrolled autonomic dysreflexia
6. Individuals who are pregnant or planning to become pregnant, and who may be breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility: number of stimulation sessions attended	From start to end of treatment at 2 weeks	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	From start to end of treatment at 2 weeks	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	From start to end of each stimulation treatment	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	From start to end of each stimulation treatment	Heart rate will be taken immediately before each stimulation session, every 10 minutes during the 30-minute session, and after completion of each session
Pain levels	At the end of each stimulation session	Participants will be asked to rate their average pain during each session of stimulation (numerical rating scale from 0-10, 10 being maximum pain)
Bladder continence	prior to the start of stimulation period and at the end of stimulation period	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.
Skin health	At the start and end of each stimulation session	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.

Secondary Outcome Measures

Name	Time	Method
Time spent on bowel care	One week before the stimulation protocol to two weeks after the stimulation protocol	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	Before, immediately after and two weeks after the stimulation protocol	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	Before, immediately after and two weeks after the stimulation protocol	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.