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

NCT06801431 | Not Yet Recruiting FDA Device

• 1 other identifier: 56432
• Study Type: interventional
• Target: 5
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurogenic Bowel; Spinal Cord Injuries (SCI)

Keywords

neurogenic bowel; transcutaneous spinal stimulation

Outcome Measures

Primary Outcomes (7)

• 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.

  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

Secondary Outcomes (3)

• Time spent on bowel care

  One week before the stimulation protocol to two weeks after the stimulation protocol

• Satisfaction with Bowel Care

  Before, immediately after and two weeks after the stimulation protocol

• Peak cough flow

  Before, immediately after and two weeks after the stimulation protocol

Study Arms (1)

Transcutaneous spinal cord stimulation

EXPERIMENTAL

Individuals with motor complete cervicothoracic spinal cord injury admitted to tertiary inpatient rehabilitation

Device: Transcutaneous spinal cord stimulation

Interventions

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.

Transcutaneous spinal cord stimulation

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• They must have bowel care either daily or q2 days

You may not qualify if:

• 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)
• 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
• Individuals who are pregnant or planning to become pregnant, and who may be breastfeeding.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Neurogenic Bowel; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Alexander Whelan, MD

  NSHA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexander J Whelan, MD

CONTACT

9024731409; alexj.whelan@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Physical Medicine and Rehabilitation

Model Details: all patients will be treated with the transcutaneous spinal cord stimulation to see if it affects bowel movements

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 30, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share