An interventional study of Sensory NMES Modality and Motor NMES Modality in Spinal Cord Injuries (Complete and Incomplete), sponsored by Swiss Paraplegic Research, Nottwil. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment
Difficulty with bowel movements is one of the most serious side effects of spinal cord injury and one that most severely restricts everyday life. Many people affected take 30 to 60 minutes, or considerably longer, to pass stools. This is accompanied by a significantly slowed bowel transit, which often leads to a feeling of fullness, flatulence and chronic pain. The study investigates a method suitable for everyday use to support bowel function: electrical stimulation of the abdominal muscles. This involves applying adhesive electrodes to the abdomen and controlling them via a small device. The treatment is carried out independently at home - 30 minutes before each planned bowel movement. Two stimulation settings are being compared: i) Motor stimulation: The current strength causes a noticeable contraction of the abdominal muscles. ii) Sensory stimulation: The intensity is lower and is perceived merely as a gentle tingling sensation. The procedure is divided into several phases. Before stimulation begins, baseline values are recorded during a two-week pre-observation phase. Subsequently, both stimulation methods are applied one after the other for 12 weeks each, interspersed with a six-week break without stimulation. Which participant starts with which type of stimulation is determined at random. A final six-week follow-up phase assesses whether any improvements achieved persist after the end of treatment.
During the study, participants will keep a diary and, together with specialists, complete two questionnaires. Bowel transit time will be measured in a simple and safe manner (using maize grains and a capsule containing blue food colouring). In addition, stool samples will be collected at five specified time points to analyse changes in the gut microbiota. The aim is to evaluate a gentle, practical method that facilitates the bowel movement process, promotes gut health and noticeably improves the quality of life of people with spinal cord injury.
Neurogenic Bowel Dysfunction (NBD) is a debilitating complication affecting the majority of individuals with spinal cord injury (SCI), resulting from disrupted autonomic and somatic neural pathways regulating colonic peristalsis and sphincter control. Clinically, NBD manifests as prolonged defecation routines, severe constipation, fecal incontinence, and abdominal distension, with approximately 55% of individuals reporting moderate to severe deterioration in quality of life due to restrictive routines, anxiety over accidental episodes, and caregiver dependency. In severe cases, bowel management requires several hours each day and represents a leading source of secondary morbidity and hospital readmission. In addition, prolonged gastrointestinal transit in SCI alters the gut luminal environment, causing mucosal dysbiosis, depletion of beneficial short-chain fatty acid-producing taxa, and accumulation of potentially deleterious proteolytic fermentation metabolites.
Neuromuscular electrical stimulation (NMES) applied to the abdominal wall musculature is a non-invasive intervention designed to improve bowel function. Historically, abdominal NMES has been applied at suprathreshold intensities to trigger visible tetanic muscle contractions, based on the premise that increased intra-abdominal pressure mechanically facilitates colonic transit and defecation. However, pilot findings and emerging neurophysiological data indicate that sub-motor (sensory) stimulation may independently modulate autonomic enteric pathways via afferent sensory signaling to the spinal cord. In a preliminary single-center pilot trial (NCT04914975, N = 20), daily home-based abdominal NMES applied for 30 minutes prior to scheduled bowel care significantly reduced defecation time and whole-gut transit time. Notably, participants with neurological injury levels below T12 who possessed intact voluntary abdominal motor control also derived clinical benefits, indicating that the underlying mechanisms extend beyond mechanical efferent activation to include sensory afferent neuromodulation.
The ESBo-SCI trial is a randomized, active-controlled, two-period cross-over clinical trial designed to compare the clinical and physiological efficacy of motor-level versus sensory-level abdominal NMES in individuals with chronic SCI. The protocol spans an overall duration of 38 weeks. Following a 2-week standardized baseline phase of prospective documentation without electrical stimulation, participants complete a 12-week intervention period (Stimulation Block I) with either motor NMES or sensory NMES as determined by randomization. This is followed by a 6-week washout phase without electrical stimulation to eliminate potential carry-over effects. Participants then cross over to the alternate stimulation modality for a second 12-week intervention period (Stimulation Block II), concluding with a 6-week follow-up observation phase to determine the durability and persistence of treatment effects. Throughout both 12-week intervention blocks, participants self-administer the stimulation at home for 30 minutes immediately preceding their scheduled bowel routine using certified, current-controlled clinical stimulators. Electrical current intensity is individualized through on-site threshold testing prior to initiating each stimulation block. The motor threshold is defined as the lowest current intensity eliciting a visible muscle twitch within the stimulated area. For the sensory NMES modality, the current amplitude is fixed at 10% below this motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction. For the motor NMES modality, current amplitude is adjusted above the motor threshold to evoke visible, robust, tetanic abdominal muscle contractions that remain comfortable and tolerable to the participant.
Participants are randomized in a 1:1 allocation to determine the sequence of interventions (motor NMES first versus sensory NMES first).
Laboratory personnel and statisticians remain blinded to treatment sequence and stimulation modality. Participants are masked to the primary study hypotheses and sequence allocation, remaining uninformed regarding which stimulation mode is hypothesized to be superior. The primary hypothesis posits that motor NMES produces a significantly greater reduction in defecation time than sensory NMES, mediated primarily by mechanical intra-abdominal pressure generation combined with efferent motor contractions. The mechanistic hypothesis posits that if sensory NMES yields equivalent or superior clinical improvements, therapeutic benefits will be attributed primarily to afferent somatosensory neuromodulation acting on autonomic spinal and enteric circuits.
A total target enrollment of 41 participants is planned to account for anticipated attrition and provide 33 evaluable participants, ensuring statistical power to detect a clinically meaningful difference in defecation time. Differences between stimulation modalities and study phases will be analyzed using repeated-measures linear mixed-effects models with a random intercept for individual participants, treating the first week of each intervention block as an accommodation run-in phase. All prospective participant logs and clinical questionnaires are managed through an encrypted, web-based electronic data capture system using dedicated tablet computers.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 41 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Swiss Paraplegic Research, Nottwil is the lead sponsor of 71 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stimulation is delivered via two independent channels using four self-adhesive surface electrodes placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles. Stimulation is administered with a symmetrical rectangular biphasic current, 40 Hz, 300 µs. Threshold testing is performed at on-site visits prior to initiating each stimulation block: Motor Threshold Definition: The lowest electrical current intensity eliciting a visible muscle twitch within the stimulated abdominal area. In this modality, the sensity modality, the current amplitude is fixed at 10% below the individually determined motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction. Participants will stimulate with their individually determined amplitude.
Other: Motor NMES Modality
Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles. Current Type: Symmetrical rectangular biphasic current. Frequency: 40 Hz. Pulse Duration: 300 microseconds (µs). Duty Cycle: 8 seconds ON (incorporating 2 seconds ramp-up and 2 seconds ramp-down) followed by 3 seconds OFF. In this modality, the motor NMES modality, the current amplitude is adjusted above motor threshold to evoke a visible, robust, tetanic abdominal muscle contraction that remains comfortable and tolerable to the participant. Participants will stimulate with their individually determined amplitude, that is above the sensory threshold.
Other: Sensory NMES Modality
Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles. * Current Type: Symmetrical rectangular biphasic current. * Frequency: 40 Hz. * Pulse Duration: 300 µs. Threshold testing is performed at on-site visits prior to initiating each stimulation block: * Motor Threshold Definition: The lowest electrical current intensity eliciting a visible muscle twitch within the stimulated abdominal area. * Sensory NMES Modality: Current amplitude is fixed at 10% below the individually determined motor threshold, ensuring activation of cutaneous and subcutaneous sensory afferents without triggering visible muscle contraction.
Stimulation is delivered via two independent channels using four self-adhesive surface electrodes (5 cm × 9 cm; Axelgaard PALS) placed bilaterally across the abdominal wall over the rectus abdominis and external oblique muscles. * Current Type: Symmetrical rectangular biphasic current. * Frequency: 40 Hz. * Pulse Duration: 300 microseconds (µs). * Duty Cycle: 8 seconds ON (incorporating 2 seconds ramp-up and 2 seconds ramp-down) followed by 3 seconds OFF. Motor NMES Modality: Current amplitude is adjusted above motor threshold to evoke a visible, robust, tetanic abdominal muscle contraction that remains comfortable and tolerable to the participant.
Defecation time
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).
Time frame: Defecation time will be assessed with a stool diary over the entire study period of 38 week depending on the bowel movements per week.
Defecation Time (Minutes)
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).
Time frame: 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
Whole-Gut Transit Time (WGTT)
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.
Time frame: The Blue Dye Test will performed 5 times over the entire study period of 38 weeks.
Whole-Gut Transit Time (WGTT)
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.
Time frame: The Corn Test will performed 5 times over the entire study period of 38 weeks.
Stool Consistency
Bristol Stool Form Scale (BSFS; range: Type 1 \[separate hard lumps\] to Type 7 \[entirely liquid\]), logged per defecation event
Time frame: 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.
Neurogenic Bowel Dysfunction (NBD) Score
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).
Time frame: The NBD score will be assessed 5 times over the entire study period of 38 weeks.
Gastrointestinal Quality of Life Index (GIQLI)
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.
Time frame: The GIQLI will be assessed 5 times over the entire study period of 38 weeks.
Gut Microbiome Profiling
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.
Time frame: The Gut Microbiome Profiling consisting of stool probes will be assessed 5 times over the entire study period of 38 weeks.
Defecation Diary Metrics-absolut defecation time
Daily tracking includes time of routine initiation, first stool expulsion, last stool expulsion as the absolute defecation time.
Time frame: The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-relative defecation time
Daily tracking includes time of clean-up start and completion to calculate the relative defecation time.
Time frame: The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-rountinely defecation interventions
Daily tracking includes time of individual defecation interventions
Time frame: The diary will be filled in electronically on daily base over the entire study period of 38 weeks.
Defecation Diary Metrics-stimulation parameter
The diary includes the stimulation parameter in terms of intensity (amplitude mA)
Time frame: The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Defecation Diary Metrics-stimulation time
The diary includes the stimulation time (minutes)
Time frame: The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Defecation Diary Metrics-stimulation posture
The diary includes participants' posture during stimulation
Time frame: The stimulation parameter will be filled in electronically during the two stimulation periods of 12 weeks each.
Nutritional Confounders
Dietary intake is assessed by using the Cambridge Food Frequency Questionnaire (FFQ).
Time frame: The Nutritional Confounders will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder frequency of physical activity
Frequency of weekly physical activity will be documented
Time frame: This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder duration of physical activity
Duration of weekly physical activity will be documented
Time frame: This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Lifestyle Confounder type of physical activity
Type of weekly physical activity will be documented
Time frame: This Lifestyle Confounder will be assessed twice at baseline (day 1) and at study completion (day 1-3, week 38).
Plan to share: No
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Swiss Paraplegic Research, Nottwil