NCT05991804 Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
| NCT ID | NCT05991804 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University College, London |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-06-28 |
| Primary Completion | 2028-04-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2023-06-28 with a primary completion date of 2028-04-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each year, with around half of these injuries affecting the cervical spine. People who have reduced function and control affecting their upper limbs may have difficulty carrying out activities of daily living (ADLs), significantly affecting their independence. Recovering even partial upper limb function is a top priority among tetraplegics. Regaining voluntary function in the upper limb can have a huge impact on quality of life. Using TSCS in the upper limb for acute SCI can benefit patients early in their rehabilitation, and may reduce the number of patients with problematic spasticity at discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of improving function and spasticity in this cohort. The aim of this feasibility study is to assess and compare the impact of adding TSCS to the standard rehabilitation of inpatients with acute SCI, compared to a sham (placebo) TSCS intervention added to standard rehabilitation, in an effort to enhance upper limb control and function.
Eligibility 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
Contact & Investigator
Lynsey Duffell, PhD
PRINCIPAL INVESTIGATOR
University College, London
Frequently Asked Questions
Who can join the NCT05991804 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05991804 currently recruiting?
Yes, NCT05991804 is actively recruiting participants. Contact the research team at joseph.steel@nhs.net for enrollment information.
Where is the NCT05991804 trial being conducted?
This trial is being conducted at London, United Kingdom.
Who is sponsoring the NCT05991804 clinical trial?
NCT05991804 is sponsored by University College, London. The principal investigator is Lynsey Duffell, PhD at University College, London. The trial plans to enroll 18 participants.