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

Not Applicable

• Conditions: Abdominal pain; spinal cord injury; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12624000010594
• Lead Sponsor: Royal North Shore Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with spinal cord injury for at least 12 months
Currently experiencing abdominal symptoms, including abdominal pain/discomfort

Exclusion Criteria

Unable to complete questionnaires – whether due to impaired cognition or language barrier
Unable to deliver vagal nerve stimulation by him/herself OR does not have someone else who can deliver the VNS
Unable to attend required face-to-face visits
Any other implant device that may interfere with vagal nerve stimulation
Underlying significant cardiac abnormality, especially cardiac arrhythmia
(Relative contraindication) History of recurrent or severe autonomic dysreflexia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain scale - Ten point visual analogue scale<br>[ Assessed using at week 0, 4, 8 and 12. Ten point visual analogue was designed based from international spinal cord injury pain basic data set/ bowel function data set.];Abdominal pain map - Participant marks locations of the pain on diagram of abdomen/back[ Assessed using online questionnaire at week 0, 4, 8 and 12. This online interactive abdominal pain map was developed specifically for this study.]

Secondary Outcome Measures

Name	Time	Method
Colonic motility[ Assessed using abdominal x-ray after consuming oral contrast marker(Eg. Sitzmark) at week 0 and 12];Autonomic dysreflexia[ Patients will be asked if they had autonomic dysreflexia event at 0, 4, 8 and 12. No specific pre-validated questionnaire was used.];Quality of life using ten point visual analogue scale.[ Assessed using at week 0, 4, 8 and 12. Ten point visual analogue was designed based from international spinal cord injury pain basic data set/ bowel function data set.]