Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI
NCT07929558, Not applicable, Not yet recruiting, Swiss Paraplegic Research, Nottwil
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI | ClinicalTrials.gov |
| NCT number | NCT07929558 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 41 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Swiss Paraplegic Research, Nottwil | ClinicalTrials.gov |
| Conditions | Spinal Cord Injuries (Complete and Incomplete) | ClinicalTrials.gov |
| Interventions | Sensory NMES Modality, Motor NMES Modality | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Defecation time | Defecation time will be assessed with a stool diary over the entire study period of 38 week depending on the bowel movements per week. | Defined as the elapsed duration from the expulsion of the first stool until the expulsion of the last stool. Participants prospectively record precise timestamps for each bowel routine in a daily electronic diary. The primary endpoint is the intra-individual change in mean weekly defecation time between baseline and the two stimulation modalities (excluding the first week of each stimulation block as a run-in phase). | ClinicalTrials.gov |
| Primary | Defecation Time (Minutes) | Defecation will be assessed in form of a diary over the entire study period of 38 weeks depending on the number of defecation sessions per week | Defined as the elapsed duration from the expulsion of the first stool until the expulsion of the last stool. Participants prospectively record precise timestamps for each bowel routine in a daily electronic diary. The primary endpoint is the intra-individual change in mean weekly defecation time between baseline and the two stimulation modalities (excluding the first week of each stimulation block as a run-in phase). | ClinicalTrials.gov |
| Secondary | Whole-Gut Transit Time (WGTT) | The Blue Dye Test will performed 5 times over the entire study period of 38 weeks. | Evaluated using a validated home test administered prior to study visits: Standardized Blue Dye Test: Following an overnight fast (≥8 hours), participants ingest two plain rice crackers and swallow a single 0.68 mL gelatin capsule containing 0.25 g food-grade blue dye powder (\~60 mg combined E131/E132; Hollinger Farbpulver Blau) with \~100 mL water. Diet, activity, and bowel medications remain unchanged, with intensely colored foods avoided for 48 hours. WGTT is defined as the duration between capsule ingestion and the first appearance of blue or blue-green stool. | ClinicalTrials.gov |
| Secondary | Whole-Gut Transit Time (WGTT) | The Corn Test will performed 5 times over the entire study period of 38 weeks. | Evaluated using a validated home test administered prior to study visits: Corn Test: Ingestion of 140 g of canned sweetcorn; elapsed time to the first visual identification of excreted corn kernels is recorded. | ClinicalTrials.gov |
| Secondary | Stool Consistency | The BSFS is included in the stool diary and will be filled in at the every defecation time point over the entire study period of 38 weeks. | Bristol Stool Form Scale (BSFS; range: Type 1 \[separate hard lumps\] to Type 7 \[entirely liquid\]), logged per defecation event | ClinicalTrials.gov |
| Secondary | Neurogenic Bowel Dysfunction (NBD) Score | The NBD score will be assessed 5 times over the entire study period of 38 weeks. | Validated 10-item clinical questionnaire assessing fecal incontinence, constipation, defecation duration, medication dependence, and lifestyle restriction (total score 0 to 47; higher scores indicate greater severity). | ClinicalTrials.gov |
| Secondary | Gastrointestinal Quality of Life Index (GIQLI) | The GIQLI will be assessed 5 times over the entire study period of 38 weeks. | Total Score Range: 0 to 144 points (derived from 36 items, each rated on a 5-point Likert scale from 0 to 4). Higher scores indicate a better quality of life, meaning fewer symptoms and better daily functioning. Disease-specific health-related quality of life instrument evaluating gastrointestinal symptoms, physical functioning, emotional state, social performance, and medical treatment burden. | ClinicalTrials.gov |
| Secondary | Gut Microbiome Profiling | The Gut Microbiome Profiling consisting of stool probes will be assessed 5 times over the entire study period of 38 weeks. | Fecal samples are collected at scheduled visits using ambient-temperature DNA stabilization kits (DNA Genotek) or home frozen at -20°C prior to transport on cold packs and storage at -80°C. Stool aliquots undergo enzymatic pre-lysis and bead-beating prior to silica-membrane DNA purification. Full-length 16S rRNA genes (V1-V9 regions, \~1.5 kb) are amplified (primers 27F/1492R) and sequenced on Oxford Nanopore MinION platforms. Sequences are demultiplexed, filtered (Q ≥ 10; 1,400-1,650 bp), and taxonomically classified against the SILVA 138 database to quantify alpha/beta diversity and relative abundance of short-chain fatty acid-producing versus inflammation-associated taxa. | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-absolut defecation time | The diary will be filled in electronically on daily base over the entire study period of 38 weeks. | Daily tracking includes time of routine initiation, first stool expulsion, last stool expulsion as the absolute defecation time. | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-relative defecation time | The diary will be filled in electronically on daily base over the entire study period of 38 weeks. | Daily tracking includes time of clean-up start and completion to calculate the relative defecation time. | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-rountinely defecation interventions | The diary will be filled in electronically on daily base over the entire study period of 38 weeks. | Daily tracking includes time of individual defecation interventions | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-stimulation parameter | The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each. | The diary includes the stimulation parameter in terms of intensity (amplitude mA) | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-stimulation time | The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each. | The diary includes the stimulation time (minutes) | ClinicalTrials.gov |
| Secondary | Defecation Diary Metrics-stimulation posture | The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each. | The diary includes participants' posture during stimulation | ClinicalTrials.gov |
| Secondary | Nutritional Confounders | The Nutritional Confounders will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38). | Dietary intake is assessed by using the Cambridge Food Frequency Questionnaire (FFQ). | ClinicalTrials.gov |
| Secondary | Lifestyle Confounder frequency of physical activity | This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38). | Frequency of weekly physical activity will be documented | ClinicalTrials.gov |
| Secondary | Lifestyle Confounder duration of physical activity | This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38). | Duration of weekly physical activity will be documented | ClinicalTrials.gov |
| Secondary | Lifestyle Confounder type of physical activity | This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38). | Type of weekly physical activity will be documented | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41146588 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)