Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI

Trial details

Who runs it

Swiss Paraplegic Research, Nottwil

Trial code

NCT07929558

Record updated

10 November 2026

Original description

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.Read full original descriptionShow less

ESBo-SCI: Abdominal Neuromuscular Electrical Stimulation to Treat Neurogenic Bowel Dysfunction in Chronic SCI

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.

Inclusion: Traumatic or non-traumatic spinal cord injury; Neurological level of injury C1 to L5; American Spinal Injury Association (ASIA) Impairment Scale (AIS) grade A, B, C, or D; Chronicity ≥1 year post-injury; Age ≥18 years; Documented defecation time >30 minutes per routine with an expressed desire to reduce time spent on bowel care; Established and stable conservative bowel management protocol; Signed informed consent.

Exclusion: Concurrent regular opioid therapy; Prior surgical diversion of the gastrointestinal tract (e.g., colostomy, ileostomy); Active chronic inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis); Active malignant disease in the abdominal or pelvic region; Pregnancy (confirmed via urine pregnancy test in females of childbearing potential aged 18-49 years); Patients currently undergoing primary acute rehabilitation; Presence of an implanted sacral anterior root stimulator (Brindley stimulator); Open skin lesions or active dermatological defects at designated electrode placement sites; Exacerbation of severe autonomic dysreflexia provoked during electrical stimulation testing; Inability to comply with study protocols or operate the device due to substantial cognitive deficits or language barriers.

ClinicalTrials.gov NCT07929558