Neurogenic BowelNCT06801431
Transcutaneous Spinal Cord Stimulation for Bowel Management in Individuals with Motor Complete Spinal Cord Injury
A study testing Transcutaneous spinal cord stimulation in people with Neurogenic Bowel and Spinal Cord Injuries (SCI), run by Nova Scotia Health Authority.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neurogenic Bowel, Spinal Cord Injuries (SCI)
- What is being tested?
- Transcutaneous spinal cord stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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)
- Being tested
- Transcutaneous spinal cord stimulation
- Keywords
- neurogenic bowel, transcutaneous spinal stimulation
- Medical subject headings
- Neurogenic Bowel, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous spinal cord stimulation | Experimental | Individuals with motor complete cervicothoracic spinal cord injury admitted to tertiary inpatient rehabilitation Receives: Device: Transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: At the start and end of each stimulation session
Secondary outcomes (3)
Time spent on bowel care
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.
Measured: One week before the stimulation protocol to two weeks after the stimulation protocol
Satisfaction with Bowel Care
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.
Measured: Before, immediately after and two weeks after the stimulation protocol
Peak cough flow
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.
Measured: Before, immediately after and two weeks after the stimulation protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic BowelStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all patients will be treated with the transcutaneous spinal cord stimulation to see if it affects bowel movements
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Whelan, Nova Scotia Health Authority
- Investigators
- Alexander Whelan, MD, Principal investigator, NSHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801431
- Sponsor's protocol ID
- 56432
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06801431
- Acronym / sponsor ID
- 56432
- Conditions
- Neurogenic Bowel, Spinal Cord Injuries (SCI)
- Keywords
- neurogenic bowel, transcutaneous spinal stimulation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 30 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients will be treated with the transcutaneous spinal cord stimulation to see if it affects bowel movements
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous spinal cord stimulation | Experimental | Device: Transcutaneous spinal cord stimulationIndividuals with motor complete cervicothoracic spinal cord injury admitted to tertiary inpatient rehabilitation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulationIndividuals 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. | Device | Transcutaneous spinal cord stimulation |
Primary outcome
Feasibility: number of stimulation sessions attended
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Whelan, MD principal investigator
NSHA
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord stimulation in people with Neurogenic Bowel and Spinal Cord Injuries (SCI), run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander J Whelan, MD (9024731409, alexj.whelan@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: number of stimulation sessions attended (time frame: From start to end of treatment at 2 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.