Efficacy of a Wearable Noninvasive Neuromodulation Device

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)

Overview

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.

Interventions

• Device 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 compl
• 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 compl
• 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.

Primary outcome measures

• The Neurogenic Bowel Dysfunction (NBD) score [Time frame: Baseline (phase-in) to 4-week visit]
• Prolonged colonic transit measurement to assess NBD severity [Time frame: Baseline and approximately the 4-week post treatment visit]

Secondary outcome measures (12)

• 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07171489 · HUM00279126 · 1UG3NS125182-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗