Noninvasive vagal nerve stimulation for abdominal symptoms in people with spinal cord injury

Transcutaneous vagal nerve stimulation delivered by a hand-held device around the neck -gammaCore(Transcutaneous VNS device) is a size of the card deck and is battery operated. It produces an electrical signal that consists of five 5000 Hz pulses. This pulse is repeated at a rate of 25 Hz. The waveform produced by this device is approximately sign wave. -Initial stimulation will be delivered by nursing staff/doctor involved in study. -Participants will deliver 2 minutes of stimulation on each side of the neck or scapula (total 4 minutes) twice a day (total 8 minutes). -Participants will complete 4 weeks of stimulation on each site with 2 weeks wash-out period. -Participants are to complete the treatment diary to record the stimulations delivered Visit schedules -The participant will complete baseline questionnaire prior to the first visit : This will assess participant’s medical history including nature of spinal cord injury, bowel function, picture map of abdominal pain, character of the pain, non-abdominal pain, quality of life questions, hospital anxiety and depression questionnaire and Rome questionnaire for disorders of gut-brain interaction. -There will be 2 weeks lead-in period before the first visit. -During the first visit : The participant will complete ECG and routine observations. These will be completed by either nurses/doctors involved in clinical trial. They may also receive abdominal x-ray and abdominal ultrasound. X-ray will be done at hospital radiology department. Ultrasound may be done at bed side by the doctor involved in this study. -After this, the participant will undergo the first stimulation. First stimulation will be same in duration as routine as described above. Depending on the randomisation, stimulation will be at neck of scapula. - If the first stimulation is successful, a participant (or carer) will be educated about how to use the VNS device and given a device to take home. Education will be done by the nurse/doctor involved in this clinical trial and will be approximately 15-30 minutes -The participant will continue to deliver stimulation as per above schedule and will be asked to keep the diary for 4 weeks. -At the end of 4 weeks, participant will have another visit to check on progress and ECG. -The participant will be instructed to stimulate alternate sites for 4 weeks after 2 weeks wash-out period. -On week 10, the participant will have end of treatment visit and ECG. -The participant will complete the ‘progress questionnaire’ at week -2, 0, 4, 6 and 10. The progress questionnaire consists of questions addressing abdominal pain location (using a diagram), severity of abdominal pain, number of bowel motions, quality of life questions and hospital anxiety and depression score. - Overall treatment duration will be 10 weeks. (4 weeks of each stimulation site + 2 weeks wash-out period) The protocol was changed prior to the commencement of recruitment.(2024 Sep)