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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3NS125182-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham (TNM at a sham-point) -Randomized arm | Sham Comparator | 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. |
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| Transcutaneous neuromodulation (TNM) at a leg point-Randomized arm | Experimental | Participants will have a 2-week phase-in period followed by a 4-week treatment phase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TNM at a sham-point (AccelBand) - randomized arm | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Neurogenic Bowel Dysfunction (NBD) score | 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. | Baseline (phase-in) to 4-week visit |
| Prolonged colonic transit measurement to assess NBD severity | 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. | Baseline and approximately the 4-week post treatment visit |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Medication use for neurogenic bowel use | Use of medications: name, dose, frequency of medications and duration. | Baseline (phase-in) to 4-week visit |
| Bowel routine techniques | Duration and types of bowel routine techniques will be tracked by the bowel diary application (app). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caitlyn Fisher | Contact | 734-998-7285 | fishercj@med.umich.edu |
| Name | Affiliation | Role |
|---|---|---|
| Gianna Rodriguez, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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The randomized 4-week treatment period will be double-blinded for TNM and sham-TNM except for the study coordinator. Participants are unblinded at the 4-week post treatment visit. Of note, sham participants have the option of having a 2-week open label of treatment following the randomized treatment.
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| TNM at a leg point (AccelBand)- randomized arm | 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. |
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| TNM at a leg point (AccelBand)- open-label | 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. |
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| Baseline (phase-in) to 4-week visit |
| Number of bowel movements per week | This will be tracked by the bowel diary application (app). | Baseline (phase-in) to 4-week visit |
| Bristol stool form scale (BSFS) | 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. | Baseline (phase-in) to 4-week visit |
| SCI Quality of Life Bowel Management Difficulties survey (SCI QoL-BMD) | 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. | Baseline (phase-in) to 4-week visit |
| Gastrointestinal Symptom Rating Scale (GSRS) | 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. | Baseline (phase-in) to 4-week visit |
| Number of Adverse events (serious and non-serious) | The severity, relatedness, and expectedness will be noted (per protocol) by the following:
| Baseline to post treatment visit (approximately 4 weeks) |
| Fecal loading in the colon | 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. | Baseline and approximately the 4-week post treatment visit |
| Anorectal Manometry Test (AMT) - sensory thresholds | 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. | approximately 4-week post treatment visit |
| Anorectal Manometry Test (AMT) - rectal inhibitory reflex | This will be assessed at the clinic with anorectal manometry (ARM). | approximately 4-week post treatment visit |
| Anorectal Manometry Test (AMT) - external anal sphincter (EAS) and rectum pressures at rest and during strain | This will be assessed at the clinic with Anorectal manometry (ARM). | approximately 4-week post treatment visit |
| Anorectal Manometry Test (AMT) - Paradoxical external anal sphincter contraction | This will be assessed at the clinic with Anorectal manometry (ARM). | approximately 4-week post treatment visit |
| D014947 | Wounds and Injuries |