Clinical trial NCT06801431: Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury
Official title: A Pilot Study on the Tolerance, Feasibility, and Impact of Transcutaneous Spinal Cord Stimulation on Bowel Management in Individuals with Motor Complete Spinal Cord Injury Receiving Inpatient Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neurogenic Bowel
Spinal Cord Injuries (SCI)
Keywords: neurogenic bowel
transcutaneous spinal stimulation
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all patients will be treated with the transcutaneous spinal cord stimulation to see if it affects bowel movements
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: number of stimulation sessions attended
timeFrame: From start to end of treatment at 2 weeks
measure: Feasibility: duration of stimulation tolerated per session
timeFrame: From start to end of treatment at 2 weeks
measure: Blood Pressure
timeFrame: From start to end of each stimulation treatment
measure: Heart rate
timeFrame: From start to end of each stimulation treatment
measure: Pain levels
timeFrame: At the end of each stimulation session
measure: Bladder continence
timeFrame: prior to the start of stimulation period and at the end of stimulation period
measure: Skin health
timeFrame: At the start and end of each stimulation session
Secondary outcomes:
measure: Time spent on bowel care
timeFrame: One week before the stimulation protocol to two weeks after the stimulation protocol
measure: Satisfaction with Bowel Care
timeFrame: Before, immediately after and two weeks after the stimulation protocol
measure: Peak cough flow
timeFrame: Before, immediately after and two weeks after the stimulation protocol
Other outcomes:
Locations:
Study officials:
affiliation: NSHA
name: Alexander Whelan, MD
role: PRINCIPAL_INVESTIGATOR
References: