Neuromodulation Device for Spinal Cord Injury

Overseen By Caitlyn Fisher

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must not be taking: Opioids

Disqualifiers: Cognitive impairment, Diabetes, Psychiatric disorder, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new device, AccelBand, designed to assist individuals with spinal cord injury (SCI) who experience slow digestion and constipation, known as neurogenic bowel dysfunction (NBD). The researchers aim to determine if the device, which uses transcutaneous neuromodulation (TNM), can improve these symptoms compared to a placebo treatment. The trial seeks individuals who have had a spinal cord injury for at least six months and experience bowel issues due to this injury. Participants will receive either the active treatment or a sham treatment to compare results. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance the quality of life for those with SCI.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking opioid medications daily.

What prior data suggests that this neuromodulation device is safe for treating neurogenic bowel dysfunction in spinal cord injury patients?

Research has shown that the AccelBand device, which employs transcutaneous neuromodulation (TNM), is safe for people with spinal cord injuries (SCI). Studies have found that this type of device can be safely used alongside rehab exercises for those with SCI. These studies have reported no major safety issues, suggesting that the treatment is generally well-tolerated.

Although specific data from this trial is not yet available, similar treatments have not caused serious problems in the past, indicating a positive safety outlook. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for spinal cord injury, which often focus on physical therapy and medication to manage symptoms, the AccelBand offers a unique approach through neuromodulation. This device uses transcutaneous neuromodulation (TNM), a non-invasive method that stimulates nerve activity via the skin at specific leg points. Researchers are excited because this technique has the potential to directly enhance nerve communication and improve motor function, offering a promising alternative to more invasive procedures or pharmacological interventions. The possibility of delivering treatment without surgery and seeing quicker results makes the AccelBand a promising candidate in the field of spinal cord injury recovery.

What evidence suggests that this neuromodulation device is effective for neurogenic bowel dysfunction in spinal cord injury patients?

Research suggests that transcutaneous neuromodulation (TNM) might help with bowel issues in people with spinal cord injuries. In this trial, participants will receive either TNM at a leg point or a sham treatment. Studies have shown that TNM can enhance the body's automatic functions, which are crucial for bowel control. Although specific data on TNM's effects on bowel problems is limited, similar methods have shown promise in aiding recovery and improving bodily functions in people with spinal cord injuries. A related technique, transcutaneous spinal cord stimulation, has been linked to better recovery after spinal cord injuries. These findings suggest that TNM could potentially reduce constipation and improve bowel function for those with spinal cord injuries. ^{2 6 7 8 9}

Who Is on the Research Team?

Gianna Rodriguez, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury (SCI) above T12, who have incomplete sensory function or better and suffer from neurogenic bowel dysfunction due to SCI. They must be at least 6 months post-injury and able to consent. Exclusions include substance abuse, severe psychiatric disorders, electrical implants like pacemakers, pregnancy plans, ventilator dependency, severe autonomic dysreflexia, complete leg sensation loss, diabetes mellitus diagnosis, significant cognitive issues preventing informed consent or survey completion.

Inclusion Criteria

Post-SCI time ≥ 6 months

Willing to sign the informed consent form

I have a spinal cord injury.

Exclusion Criteria

Known current substance abuse

Known current or past severe significant psychiatric disorder

Implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Phase-in

Participants undergo a 2-week phase-in period to acclimate to the study conditions

2 weeks

Treatment

Participants receive either the active TNM treatment or a sham treatment for 4 weeks

4 weeks

Open-label extension (optional)

Sham participants can elect to have 2 weeks of open-label treatment once unblinded

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AccelBand

Trial Overview The study tests a wearable neuromodulation device called AccelBand on people with SCI-related bowel dysfunction. It compares the effects of TNM treatment at a leg point against a sham (fake) intervention to see if it improves symptoms and autonomic function. Participants are either in an open-label group knowing they're getting real treatment or randomized without knowing if they get the real or sham therapy.

How Is the Trial Designed?

Group I: Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm Experimental Treatment 1 Intervention

Participants will have a 2-week phase-in period followed by a 4-week treatment phase.

Group II: Sham (TNM at a sham-point) -Randomized arm Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12548825/

Effectiveness of Transcutaneous Spinal Cord Stimulation for ... This comprehensive systematic review and meta-analysis will address an important evidence gap, providing the first focused evaluation of tSCS ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... Combined tSCS + ABT facilitated functional recovery after chronic SCI. Improvements required ≥60 tSCS-ABT sessions, with further exposure to tSCS facilitating ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05669508

Wearable Electrical Stimulation on the Back to Modulate ... The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and ...

4. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02689-y

Neuromodulation techniques for the treatment of spinal cord ... This study aims to comprehensively review the latest research advancements in spinal cord injury neurostimulation technologies, explore their practical ...

5. frontiersin.org frontiersin.org/journals/rehabilitation-sciences/articles/10.3389/fresc.2021.740307/full

Transcutaneous Electrical Spinal Cord Stimulation to ... To evaluate the impact of using transcutaneous electrical spinal cord stimulation (TSCSTSCS) on upper and lower extremity function in individuals with chronic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12014404/

Cardiovascular safety of transcutaneous spinal cord ... This study supports the safety profile of cervical tSCS paired with rehabilitation in individuals with cervical spinal cord injury. The lack of ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06000592

Safety, Feasibility, and Efficacy of TSCS on Stabilizing ... This project will provide the foundational evidence to support the feasible and safe application of TSCS for widespread clinical utility in the newly injured ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39998450

Safety and Effectiveness of Multisite Transcutaneous ... These findings indicate that prolonged training with tSCS-ABT can be an effective neuromodulatory intervention for individuals with SCI.

9. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and ...