Spinal Cord Injuries Clinical Trial
— FES_BowelOfficial title:
The Effect of Neuromuscular Electrical Stimulation on Bowel Management in People With Chronic Spinal Cord Injury - a Pilot Study
It has been reported that 62% of all people with Spinal Cord Injury (SCI) have experienced faecal incontinence and that neurogenic bowel dysfunction (NBD) is a major sequela. As an alternative to abdominal massage or the use of suppositories, the electrical stimulation (ES) of the abdominal wall has been shown to be effective in decreasing the bowel transit time as well as decreasing constipation in children with slow-transit constipation. Due to the intrinsic nature of the guts' innervation, we expect to reproduce these positive effects in people with SCI through administration of neuromuscular electrical stimulation (NMES).
Status | Recruiting |
Enrollment | 20 |
Est. completion date | July 31, 2024 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Traumatic and non-traumatic SCI; > 1 year - Level of lesion: C2 - L5 - AIS score A/B/C/D - Age: = 18 years - Urge to reduce defaecation time Exclusion Criteria: - Patients during primary rehabilitation - Bladder stimulator - Autonomic dysreflexia by application of ES of the abdominal wall - Pregnancy: test in women of childbearing age (15 - 49 years) - Opioid use - Inflammatory bowel disease - Cancerous tissue in abdominal region - Patients' inability to follow the study, e.g. mental-health problems, language problems, dementia etc. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Paraplegic Centre | Nottwil | LU |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Research, Nottwil |
Switzerland,
Benevento BT, Sipski ML. Neurogenic bladder, neurogenic bowel, and sexual dysfunction in people with spinal cord injury. Phys Ther. 2002 Jun;82(6):601-12. — View Citation
Clarke MC, Catto-Smith AG, King SK, Dinning PG, Cook IJ, Chase JW, Gibb SM, Robertson VJ, Di Simpson, Hutson JM, Southwell BR. Transabdominal electrical stimulation increases colonic propagating pressure waves in paediatric slow transit constipation. J Pe — View Citation
Korsten MA, Fajardo NR, Rosman AS, Creasey GH, Spungen AM, Bauman WA. Difficulty with evacuation after spinal cord injury: colonic motility during sleep and effects of abdominal wall stimulation. J Rehabil Res Dev. 2004 Jan-Feb;41(1):95-100. doi: 10.1682/ — View Citation
Krassioukov A, Eng JJ, Claxton G, Sakakibara BM, Shum S. Neurogenic bowel management after spinal cord injury: a systematic review of the evidence. Spinal Cord. 2010 Oct;48(10):718-33. doi: 10.1038/sc.2010.14. Epub 2010 Mar 9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Qualiveen Short Form (SF) | Qualiveen SF to assess bladder function | 24 weeks; 5 times | |
Other | International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) | International Standards to document remaining Autonomic Function after Spinal Cord Injury (ISAFSCI) | 24 weeks; 5 times | |
Other | Questionnaire of treatment effectiveness | Questionnaire of treatment effectiveness containing 3 questions about the application of the stimulation | 24 weeks; 2 times | |
Primary | Neurogenic Bowel Dysfunction Score (NBDS) and the defaecation time from the stimulation protocol | Investigation of the effect of NMES on the change in defaecation time (minutes) and its relation to the change in NBDS between the follow-up visits and baseline | 24 weeks | |
Secondary | Corn Test | "Corn Test" assessing bowel transit time | 24 weeks; 5 time points | |
Secondary | Bristol Stool Form Scale (BSFS) | BSFS for stool consistency | 24 weeks; at each defaecation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06321172 -
Muscle and Bone Changes After 6 Months of FES Cycling
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Recruiting |
NCT05484557 -
Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury
|
N/A | |
Suspended |
NCT05542238 -
The Effect of Acute Exercise on Cardiac Autonomic, Cerebrovascular, and Cognitive Function in Spinal Cord Injury
|
N/A | |
Recruiting |
NCT05503316 -
The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System
|
N/A | |
Not yet recruiting |
NCT05506657 -
Early Intervention to Promote Return to Work for People With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT03680872 -
Restoring Motor and Sensory Hand Function in Tetraplegia Using a Neural Bypass System
|
N/A | |
Recruiting |
NCT04105114 -
Transformation of Paralysis to Stepping
|
Early Phase 1 | |
Completed |
NCT04221373 -
Exoskeletal-Assisted Walking in SCI Acute Inpatient Rehabilitation
|
N/A | |
Completed |
NCT00116337 -
Spinal Cord Stimulation to Restore Cough
|
N/A | |
Completed |
NCT03898700 -
Coaching for Caregivers of Children With Spinal Cord Injury
|
N/A | |
Recruiting |
NCT04883463 -
Neuromodulation to Improve Respiratory Function in Cervical Spinal Cord Injury
|
N/A | |
Active, not recruiting |
NCT04881565 -
Losing Balance to Prevent Falls After Spinal Cord Injury (RBT+FES)
|
N/A | |
Completed |
NCT04864262 -
Photovoice for Spinal Cord Injury to Prevent Falls
|
N/A | |
Recruiting |
NCT04007380 -
Psychosocial, Cognitive, and Behavioral Consequences of Sleep-disordered Breathing After SCI
|
N/A | |
Active, not recruiting |
NCT04544761 -
Resilience in Persons Following Spinal Cord Injury
|
||
Terminated |
NCT03170557 -
Randomized Comparative Trial for Persistent Pain in Spinal Cord Injury: Acupuncture vs Aspecific Needle Skin Stimulation
|
N/A | |
Completed |
NCT03220451 -
Use of Adhesive Elastic Taping for the Therapy of Medium/Severe Pressure Ulcers in Spinal Cord Injured Patients
|
N/A | |
Recruiting |
NCT04811235 -
Optical Monitoring With Near-Infrared Spectroscopy for Spinal Cord Injury Trial
|
N/A | |
Recruiting |
NCT04736849 -
Epidural and Dorsal Root Stimulation in Humans With Spinal Cord Injury
|
N/A |