Efficacy of a Wearable Noninvasive Neuromodulation Device

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injuries

• Registration Number: NCT07171489
• Lead Sponsor: University of Michigan

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-05
• Study First Submitted QC: 2025-09-05
• Last Update Submitted: 2025-09-05
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-11-01
• Primary Completion: 2029-11
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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)
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Neurogenic Bowel Dysfunction (NBD) score	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	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.

Secondary Outcome Measures

Name	Time	Method
Daily Medication use for neurogenic bowel use	Baseline (phase-in) to 4-week visit	Use of medications: name, dose, frequency of medications and duration.
Bowel routine techniques	Baseline (phase-in) to 4-week visit	Duration and types of bowel routine techniques will be tracked by the bowel diary application (app).
Number of bowel movements per week	Baseline (phase-in) to 4-week visit	This will be tracked by the bowel diary application (app).
Bristol stool form scale (BSFS)	Baseline (phase-in) to 4-week visit	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.
SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD)	Baseline (phase-in) to 4-week visit	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.
Gastrointestinal Symptom Rating Scale (GSRS)	Baseline (phase-in) to 4-week visit	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.
Number of Adverse events (serious and non-serious)	Baseline to post treatment visit (approximately 4 weeks)	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
Fecal loading in the colon	Baseline and approximately the 4-week post treatment visit	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.
Anorectal Manometry Test (AMT) - sensory thresholds	approximately 4-week post treatment visit	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.
Anorectal Manometry Test (AMT) - rectal inhibitory reflex	approximately 4-week post treatment visit	This will be assessed at the clinic with anorectal manometry (ARM).
Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain	approximately 4-week post treatment visit	This will be assessed at the clinic with Anorectal manometry (ARM).
Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction	approximately 4-week post treatment visit	This will be assessed at the clinic with Anorectal manometry (ARM).

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States