Efficacy of a Wearable Noninvasive Neuromodulation Device

University of Michigan

Status: Not yet enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: TNM at a leg point (AccelBand)- randomized arm; Device: TNM at a sham-point (AccelBand) - randomized arm; Device: TNM at a leg point (AccelBand)- open-label

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07171489

1UG3NS125182-01 (U.S. NIH Grant/Contract)

HUM00279126

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Sham (TNM at a sham-point) -Randomized arm

Sham Comparator group

Description:

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.

Treatment:

Device: TNM at a leg point (AccelBand)- open-label

Device: TNM at a sham-point (AccelBand) - randomized arm

Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm

Experimental group

Description:

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

Treatment:

Device: TNM at a leg point (AccelBand)- randomized arm