Using spinal cord stimulation to improve upper limb rehabilitation
Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
NA · University College, London · NCT05991804
This study is testing if adding a gentle spinal cord stimulation treatment to regular rehab can help people with recent spinal cord injuries improve their arm function and reduce stiffness.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College, London (other) |
| Locations | 1 site (London) |
| Trial ID | NCT05991804 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of adding non-invasive transcutaneous spinal cord stimulation (TSCS) to standard inpatient rehabilitation for individuals with acute spinal cord injuries affecting the upper limbs. Participants will be randomly assigned to either receive standard rehabilitation alone or have TSCS incorporated into their treatment. The aim is to assess improvements in upper limb function and spasticity, which are critical for daily living activities. Regular assessments and follow-up interviews will be conducted to evaluate the participants' experiences and outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with recent spinal cord injuries at levels C1-C8 who are currently inpatient at the Royal National Orthopaedic Hospital.
Not a fit: Patients with certain conditions such as pregnancy, cardiac pacemakers, or other musculoskeletal diagnoses affecting the upper limbs may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance upper limb function and quality of life for patients with spinal cord injuries.
How similar studies have performed: While the use of spinal cord stimulation is gaining interest, this specific application of TSCS for upper limb rehabilitation in acute spinal cord injury is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Over the age of 18 2. Recent spinal cord injury (inpatient at the RNOH) 3. Spinal cord injury level C1-C8 4. AIS A-D 5. Willing and able to provide informed consent Exclusion Criteria: 1. Women who are pregnant, planning pregnancy or breastfeeding 2. Those who have a cardiac pacemaker 3. Active device at stimulating electrode site 4. Any other musculoskeletal diagnosis affecting the upper limbs 5. Spinal malignancy 6. Spinal cord injury due to cancerous growth 7. Auto-immune disorder 8. Ongoing infection 9. Uncontrolled autonomic dysreflexia 10. Complex regional pain syndrome 11. Neurological degenerative diseases 12. Peripheral nerve damage affecting the upper limbs 13. Taking part in a conflicting research study 14. People who are unable to tolerate TSCS during their first session
Where this trial is running
London
- Royal National Orthopaedic Hospital — London, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Lynsey Duffell, PhD — University College, London
- Study coordinator: Joseph Steel, BSc
- Email: joseph.steel@nhs.net
- Phone: 02089095500
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: Spinal Cord Injuries, Rehabilitation, Transcutaneous spinal cord stimulation, Upper limb