Efficacy of a Wearable Noninvasive Neuromodulation Device

NCT ID: NCT07171489

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-11-30

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

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.

Group Type: SHAM_COMPARATOR

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

Intervention Type: DEVICE

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-label

Intervention Type: DEVICE

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.

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

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

Group Type: EXPERIMENTAL

TNM at a leg point (AccelBand)- randomized arm

Intervention Type: DEVICE

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.

Interventions

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

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.

Intervention Type: DEVICE

TNM at a leg point (AccelBand)- randomized arm

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.

Intervention Type: DEVICE

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

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Gianna Rodriguez

Clinical Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gianna Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Central Contacts

Caitlyn Fisher

Role: CONTACT

fishercj@med.umich.edu

734-998-7285

Facility Contacts

Caitlin Fisher

Role: primary

fishercj@med.umich.edu

734-998-7285

Other Identifiers

1UG3NS125182-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00279126

Identifier Type: -

Identifier Source: org_study_id