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

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)

Interventions

DEVICE

Transcutaneous spinal cord stimulation

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.

Sponsors & Collaborators

• Nova Scotia Health Authority

  lead OTHER

Principal Investigators

• Alexander Whelan, MD · NSHA

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-09-01

Completion

2028-04-01

FDA Device

Yes