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

Overview

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.

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 H

Primary outcome measures

• Feasibility: number of stimulation sessions attended [Time frame: From start to end of treatment at 2 weeks]
• Feasibility: duration of stimulation tolerated per session [Time frame: From start to end of treatment at 2 weeks]
• Blood Pressure [Time frame: From start to end of each stimulation treatment]
• Heart rate [Time frame: From start to end of each stimulation treatment]
• Pain levels [Time frame: At the end of each stimulation session]
• Bladder continence [Time frame: prior to the start of stimulation period and at the end of stimulation period]
• Skin health [Time frame: At the start and end of each stimulation session]

Secondary outcome measures (3)

• Time spent on bowel care [Time frame: One week before the stimulation protocol to two weeks after the stimulation protocol]
• Satisfaction with Bowel Care [Time frame: Before, immediately after and two weeks after the stimulation protocol]
• Peak cough flow [Time frame: Before, immediately after and two weeks after the stimulation protocol]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06801431 · 56432

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗