Using electrical stimulation to improve bowel management for people with spinal cord injuries
A Randomised Sham-controlled, Proof of Principle Study of Abdominal Functional Electrical Stimulation (ABFES) for Bowel Management in Spinal Cord Injury (SCI)
NA · Salisbury NHS Foundation Trust · NCT04307303
This study is testing if a special electrical treatment can help people with spinal cord injuries manage their bowel function better and feel less discomfort.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Salisbury NHS Foundation Trust (other gov) |
| Locations | 1 site (Salisbury) |
| Trial ID | NCT04307303 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of abdominal functional electrical stimulation (FES) in managing bowel function for individuals with spinal cord injuries (SCI). It aims to replicate previous findings that suggest FES can reduce bowel management time, colonic transit time, and discomfort associated with constipation. The study will involve 36 participants aged 18 and over with injuries at or above the T12 level, who will be randomized into two groups: one receiving standard abdominal stimulation and the other receiving low-dose stimulation. Participants will maintain a bowel diary to track their progress over a 12-week period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a spinal cord injury at or above the T12 level and a medically stable condition.
Not a fit: Patients with conditions such as organic bowel obstruction, inflammatory bowel disease, or those using certain medications like opioids may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve bowel management and quality of life for individuals with spinal cord injuries.
How similar studies have performed: Previous exploratory studies have shown promising results for similar approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria: * People with a diagnosis of spinal cord injury * Age =\>18 years of age * Injury level at or above T12 * complete or incomplete spinal cord lesion * Medically stable condition * Reflex bowel * =\>1 year post spinal cord injury * Exclusion Criteria: * A history of organic bowel obstruction * Frequent opioid use, * Intrathecal baclofen or percutaneous endoscopic gastrostomy * Inflammatory bowel disease * Recent abdominal hernia * Recent gastrointestinal or abdominal surgery * Lower motor neuron lesions, * Suspected strictures or fistulae along the gastrointestinal tract * Physiologic gastrointestinal obstruction. * Other causes of constipation such as hypothyroidism, hypercalcaemia * Constipation predominant irritable bowel syndrome prior to diagnosis of SCI * Involvement in other research trial interventions likely to impact current trial * Poorly controlled epilepsy, * Cardiac pacemaker in situ * Other implanted electrical devices * Pregnancy or pregnancy planned * Cancerous tissue in the abdominal region * Any major skin disorders affecting the abdominal area) * Severe autonomic dysreflexia (tested at initial assessment).
Where this trial is running
Salisbury
- Salisbury NHS Foundation Trust — Salisbury, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Tamsyn Street — Salisbury NHS Foundation Trust
- Study coordinator: Tamsyn Street
- Email: Tamsyn.Street@nhs.net
- Phone: 01722 336262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neurogenic Bowel