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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (1 UK site)
Royal National Orthopaedic Hospital
London HA7 4LP, United Kingdom
How to Get in Touch
Joseph Steel, BSc
Sponsor contactCONTACT
Sarah Massey, PhD
Sponsor contactCONTACT
