Electrical Stimulation for Spinal Cord Injury
(ESBo-SCI Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Ines Bersch, PhD
Principal Investigator
Swiss Paraplegic Research, Nottwil
Are You a Good Fit for This Trial?
This trial is for adults with chronic spinal cord injury who have ongoing problems with bowel movements. Participants should be able to use electrical stimulation devices at home and follow study instructions.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Motor Neuromuscular Electrical Stimulation (NMES)
- Sensory Neuromuscular Electrical Stimulation (NMES)
Trial Overview
The study compares two types of abdominal electrical stimulation—one that causes muscle contractions (motor) and one that feels like gentle tingling (sensory)—to see which better helps people with spinal cord injuries manage bowel function. Each person tries both methods in random order.
How Is the Trial Designed?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Swiss Paraplegic Research, Nottwil
Lead Sponsor
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