Spinal Cord InjuriesNCT07171489
Efficacy of a Wearable Noninvasive Neuromodulation Device
A study testing TNM at a leg point (AccelBand)- randomized arm and TNM at a leg point (AccelBand)- open-label in people with Spinal Cord Injuries, run by University of Michigan at 1 site in United States.
Trial summary
The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- TNM at a leg point (AccelBand)- randomized arm and TNM at a leg point (AccelBand)- open-label
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Nov 2029
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Traumatic or non-traumatic spinal cord injury (SCI)
- SCI level above the twelfth thoracic vertebra (T12)
- SCI classified as Sensory Incomplete (AIS B), C, or D
- Post-SCI time ≥ 6 months;
- Neurogenic bowel dysfunction (NBD) as a result of SCI
- Willing to sign the informed consent form
Who cannot join
- Significant cognitive impairment, impeding the ability to provide informed consent or complete the questionnaire
- Prior gastrointestinal surgeries other than uncomplicated appendectomies, cholecystectomy or cesarean sections
- Known diagnosis of diabetes mellitus
- Known current or past severe significant psychiatric disorder
- Known current substance abuse
- Implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)
Show all 13Show fewer
- Taking opioid medications on a regular daily basis
- Currently pregnant or actively planning a pregnancy
- Active inflammatory bowel disease
- Ventilator dependency
- Severe autonomic dysreflexia
- No preservation of the sacral spinal reflexes: bulbocavernosus, patella, or Achilles
- Complete absence of sensation in the leg (since it is needed for calibrating the TNM intensity)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Caitlin Fisher, 734-998-7285, fishercj@med.umich.edu
Gianna Rodriguez, MD
About this study
Official title: An Early Feasibility Study of Using the AccelBand, a Leg-worn Transcutaneous Neuromodulation (TNM) Device, for Neurogenic Bowel Dysfunction (NBD) in People With Spinal Cord Injury (SCI)
The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI.
The study hypotheses:
- The proposed TNM treatment at a leg point will reduce NBD symptoms between baseline and post-therapy, when compared to the sham-TNM treatment.
- The therapeutic effect of TNM to improve the NBD symptoms is associated with improvement of the autonomic function in SCI patients.
- Conditions
- Spinal Cord Injuries
- Being tested
- TNM at a sham-point (AccelBand) - randomized arm, TNM at a leg point (AccelBand)- randomized arm, TNM at a leg point (AccelBand)- open-label
- Keywords
- Neurogenic bowel dysfunction, Transcutaneous neuromodulation, Questionnaires, AccelBand, Anorectal manometry test
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNM at a sham-point (AccelBand) - randomized armDevice
This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have.
In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial.
TNM at a leg point (AccelBand)- randomized armDevice
This will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have.
In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial.
TNM at a leg point (AccelBand)- open-labelDevice
After 4 weeks of blinded treatment sham participants will be given the option to continue open-label TNM treatment at a leg point acupoint. Participants that agree to this will be re-trained and allowed to keep the AccelBand for another 2 weeks. During this stage, participants will be asked to complete daily home-based TNM treatment and complete the daily online symptom questionnaires. Participants will complete a visit following this additional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Sham (TNM at a sham-point) -Randomized arm | Sham comparator | Participants will have a 2-week phase-in period.followed by a 4-week sham treatment.
Sham participants can elect to have 2 weeks of open-label treatment once unblinded after 4 weeks of sham. Receives: Device: TNM at a sham-point (AccelBand) - randomized arm; Device: TNM at a leg point (AccelBand)- open-label |
| Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm | Experimental | Participants will have a 2-week phase-in period followed by a 4-week treatment phase. Receives: Device: TNM at a leg point (AccelBand)- randomized arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Neurogenic Bowel Dysfunction (NBD) score
The scoring the degree of NBD symptoms and bowel routines, including frequency of bowel movements (0, 1 or 6 points), headache, perspiration or discomfort before or during defecation (0 or 2 points), medications for constipation (0, to 4 points), time used for each defecation (0, 3 or 7 points), frequency of digital stimulation or evacuation (0, 6 points), frequency of fecal incontinence (0, 6, 7 or13 points), medication for fecal incontinence (0, or 4 points), flatus incontinence (0 pr 2 points) and perianal skin problems (0 or 3 points). The score range is between 0-47 with a higher score meaning greater bowel dysfunction.
Measured: Baseline (phase-in) to 4-week visit
Prolonged colonic transit measurement to assess NBD severity
This will be assessed using abdominal X-ray (which will allow researchers to evaluate participants bowel activity over time) as the retention of radiopaque markers after ingestion of one gelatin capsule with 24 radiopaque markers, 72 hours before visit.
Measured: Baseline and approximately the 4-week post treatment visit
Secondary outcomes (12)
Daily Medication use for neurogenic bowel use
Use of medications: name, dose, frequency of medications and duration.
Measured: Baseline (phase-in) to 4-week visit
Bowel routine techniques
Duration and types of bowel routine techniques will be tracked by the bowel diary application (app).
Measured: Baseline (phase-in) to 4-week visit
Number of bowel movements per week
This will be tracked by the bowel diary application (app).
Measured: Baseline (phase-in) to 4-week visit
Bristol stool form scale (BSFS)
Bristol stool form scale scores the stool appearance for each bowel movement as proxy for colonic transit based on stool consistency (hard (1) to liquid (7) and shape tracked by the bowel diary app.
Measured: Baseline (phase-in) to 4-week visit
SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)
This survey has 26 questions with scoring of 15 factors related to feelings of distress associated with bowel management difficulties in the past week scored from 1 ("none at all" or "never") to 5 ("very much" or "always") to create the overall range of (26-130) with a higher score indicting lower quality of life.
Measured: Baseline (phase-in) to 4-week visit
Gastrointestinal Symptom Rating Scale (GSRS)
This scare uses a 7-point Likert type scale from 1 (no discomfort) to 7(very severe discomfort) to rate 15 symptom items including both upper and lower abdominal symptoms. There is a range of scores from 15-105 with a higher score indicating more discomfort.
Measured: Baseline (phase-in) to 4-week visit
Number of Adverse events (serious and non-serious)
The severity, relatedness, and expectedness will be noted (per protocol) by the following:
- Mild, Moderate, Severe
- Relationship to study products: Associated or Not associated
- Expected or unexpected
Measured: Baseline to post treatment visit (approximately 4 weeks)
Fecal loading in the colon
This will be scored from 1 to 5 from the abdominal X-rays, where: 1 - none, 2 - mild, 3 - moderate, 4 - severe, and 5 - severe with colon dilatation.
Measured: Baseline and approximately the 4-week post treatment visit
Anorectal Manometry Test (AMT) - sensory thresholds
This will be assessed at the clinic with anorectal manometry (ARM) during rectal balloon distention, sensory thresholds for the first sensation, urge to defecation, and maximal tolerance.
Measured: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - rectal inhibitory reflex
This will be assessed at the clinic with anorectal manometry (ARM).
Measured: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain
This will be assessed at the clinic with Anorectal manometry (ARM).
Measured: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction
This will be assessed at the clinic with Anorectal manometry (ARM).
Measured: approximately 4-week post treatment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startJul 2026 (estimated)
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianna Rodriguez, University of Michigan
- Investigators
- Gianna Rodriguez, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171489
- Sponsor's protocol ID
- HUM00279126
- Other IDs
- 1UG3NS125182-01
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 6 Jul 2026
- Results posted
- 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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study of Using the AccelBand, a Leg-worn Transcutaneous Neuromodulation (TNM) Device, for Neurogenic Bowel Dysfunction (NBD) in People With Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT07171489
- Acronym / sponsor ID
- HUM00279126
- Conditions
- Spinal Cord Injuries
- Keywords
- Neurogenic bowel dysfunction, Transcutaneous neuromodulation, Questionnaires, AccelBand, Anorectal manometry test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 12 Sep 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 aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI.
The study hypotheses:
- The proposed TNM treatment at a leg point will reduce NBD symptoms between baseline and post-therapy, when compared to the sham-TNM treatment.
- The therapeutic effect of TNM to improve the NBD symptoms is associated with improvement of the autonomic function in SCI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham (TNM at a sham-point) -Randomized arm | Sham comparator | Device: TNM at a sham-point (AccelBand) - randomized arm, Device: TNM at a leg point (AccelBand)- open-labelParticipants will have a 2-week phase-in period.followed by a 4-week sham treatment. Sham participants can elect to have 2 weeks of open-label treatment once unblinded after 4 weeks of sham. |
| Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm | Experimental | Device: TNM at a leg point (AccelBand)- randomized armParticipants will have a 2-week phase-in period followed by a 4-week treatment phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Traumatic or non-traumatic spinal cord injury (SCI)
- SCI level above the twelfth thoracic vertebra (T12)
- SCI classified as Sensory Incomplete (AIS B), C, or D
- Post-SCI time ≥ 6 months;
- Neurogenic bowel dysfunction (NBD) as a result of SCI
Key exclusion criteria (13 listed)
- Significant cognitive impairment, impeding the ability to provide informed consent or complete the questionnaire
- Prior gastrointestinal surgeries other than uncomplicated appendectomies, cholecystectomy or cesarean sections
- Known diagnosis of diabetes mellitus
- Known current or past severe significant psychiatric disorder
- Known current substance abuse
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 |
|---|---|---|
| TNM at a sham-point (AccelBand) - randomized armThis will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have. In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial. | Device | Sham (TNM at a sham-point) -Randomized arm |
| TNM at a leg point (AccelBand)- randomized armThis will be self-administrated by study participants (or caregivers) for a period of approximately 4 weeks twice a day (once in the morning and once in the evening daily), each lasting 60 minutes. Scheduled weekly phone calls will be provided by the study team member to assure compliance with the TNM administration and answer any questions that a participant may have. In addition to the treatment period participants will have tests completed (baseline and following treatment), as well as complete surveys during the trial. | Device | Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm |
| TNM at a leg point (AccelBand)- open-labelAfter 4 weeks of blinded treatment sham participants will be given the option to continue open-label TNM treatment at a leg point acupoint. Participants that agree to this will be re-trained and allowed to keep the AccelBand for another 2 weeks. During this stage, participants will be asked to complete daily home-based TNM treatment and complete the daily online symptom questionnaires. Participants will complete a visit following this additional treatment. | Device | Sham (TNM at a sham-point) -Randomized arm |
Primary outcome
The Neurogenic Bowel Dysfunction (NBD) score
Time frame: Baseline (phase-in) to 4-week visit
The scoring the degree of NBD symptoms and bowel routines, including frequency of bowel movements (0, 1 or 6 points), headache, perspiration or discomfort before or during defecation (0 or 2 points), medications for constipation (0, to 4 points), time used for each defecation (0, 3 or 7 points), frequency of digital stimulation or evacuation (0, 6 points), frequency of fecal incontinence (0, 6, 7 or13 points), medication for fecal incontinence (0, or 4 points), flatus incontinence (0 pr 2 points) and perianal skin problems (0 or 3 points). The score range is between 0-47 with a higher score meaning greater bowel dysfunction.
Prolonged colonic transit measurement to assess NBD severity
Time frame: Baseline and approximately the 4-week post treatment visit
This will be assessed using abdominal X-ray (which will allow researchers to evaluate participants bowel activity over time) as the retention of radiopaque markers after ingestion of one gelatin capsule with 24 radiopaque markers, 72 hours before visit.
12 secondary outcomes
Daily Medication use for neurogenic bowel use
Time frame: Baseline (phase-in) to 4-week visit
Bowel routine techniques
Time frame: Baseline (phase-in) to 4-week visit
Number of bowel movements per week
Time frame: Baseline (phase-in) to 4-week visit
Bristol stool form scale (BSFS)
Time frame: Baseline (phase-in) to 4-week visit
SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)
Time frame: Baseline (phase-in) to 4-week visit
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Baseline (phase-in) to 4-week visit
Number of Adverse events (serious and non-serious)
Time frame: Baseline to post treatment visit (approximately 4 weeks)
Fecal loading in the colon
Time frame: Baseline and approximately the 4-week post treatment visit
Anorectal Manometry Test (AMT) - sensory thresholds
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - rectal inhibitory reflex
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain
Time frame: approximately 4-week post treatment visit
Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction
Time frame: approximately 4-week post treatment visit
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 6 Jul 2026.
- 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.
Gianna Rodriguez, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TNM at a leg point (AccelBand)- randomized arm and TNM at a leg point (AccelBand)- open-label in people with Spinal Cord Injuries, run by University of Michigan at 1 site in United States.
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 13 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Caitlyn Fisher (734-998-7285, fishercj@med.umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Neurogenic Bowel Dysfunction (NBD) score (time frame: Baseline (phase-in) to 4-week visit). The study lists 2 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 6 Jul 2026.