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

A regiszter feltételei, szó szerint

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

• Sensory NMES ModalityMár használt kezelés, összehasonlításként

  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.

  Kezelés: Motor NMES Modality

• Motor NMES ModalityMár használt kezelés, összehasonlításként

  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.

  Kezelés: Sensory NMES Modality