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Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Sponsor: University College, London

NCT ID: NCT05991804

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Transcutaneous spinal cord stimulation added to inpatient rehabilitation (other), Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation (other)
How long the study runs
Study runs about 58 months (dates as stated)
About the drug or intervention
Transcutaneous spinal cord stimulation added to inpatient rehabilitation — other: Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs · Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation — other: Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
18
Started
2023-06-28
Last checked
2025-12

Plain English Summary

What is this study?

  • • Testing a new treatment for spinal cord injuries
  • • NA - 18 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with spinal cord injuries

Where?

  • • London - Royal National Orthopaedic Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Recruitment: Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our research team will contact participants after they have received this information sheet to discuss participation in the study and answer any questions. People who would like to take part in the study will be asked to attend an initial session to see if they are able to tolerate non-invasive SCS. Intervention: Eligible participants will then be randomised either into the intervention group, where they will receive TSCS or sham TSCS in addition to their regular inpatient rehabilitation. We are using this trial design to assess whether adding TSCS to regular inpatient rehabilitation enhances recovery and voluntary function in this participant cohort, and to test that there is not a placebo effect. For both the sham and intervention groups, we will carry out regular assessments. Some of these assessments will be part of standard care as an inpatient at the RNOH, and others will be additional. Please see the outcome measures for further information about these assessments. Follow-up: When participants have finished their inpatient rehabilitation at the RNOH, we will carry out a semi-structured interview, where we will ask about participants' experience on this study. Interviews may take place in person, over the phone, or over video call (e.g. Microsoft Teams or Zoom). Participants will then be invited to two Follow-up Assessments at the RNOH, where all outcome measures will be repeated. Follow-up 1 will be done once the participant is 6-months post-injury, and Follow-up 2 will be done at 1-year post-injury. If the participant is already 6-months post-injury at discharge, then Follow-up 1 will occur at 1-month post-discharge.

Spinal Cord Injuries

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What we know so far

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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Over the age of 18
  • ✓Recent spinal cord injury (inpatient at the RNOH)
  • ✓Spinal cord injury level C1-C8
  • ✓AIS A-D
  • ✓Willing and able to provide agreement to take part

Who cannot take part

  • ✗Women who are pregnant, planning pregnancy or breastfeeding
  • ✗Those who have a heart pacemaker
  • ✗Active device at stimulating electrode site
  • ✗Any other musculoskeletal diagnosis affecting the upper limbs
  • ✗Spinal cancer
See the full 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 Is This Study? (1 UK site)

Royal National Orthopaedic Hospital

London HA7 4LP, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Joseph Steel, BSc

Sponsor contact

CONTACT

02089095500 joseph.steel@nhs.net

Sarah Massey, PhD

Sponsor contact

CONTACT

07713582559 sarah.massey.13@ucl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12