Spinal Cord InjuriesUp-StimNCT05991804
Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
A study testing Transcutaneous spinal cord stimulation added to inpatient rehabilitation in people with Spinal Cord Injuries, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Transcutaneous spinal cord stimulation added to inpatient rehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2023to 16 Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent
Who cannot join
- Women who are pregnant, planning pregnancy or breastfeeding
- Those who have a cardiac pacemaker
- Active device at stimulating electrode site
- Any other musculoskeletal diagnosis affecting the upper limbs
- Spinal malignancy
- Spinal cord injury due to cancerous growth
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- Auto-immune disorder
- Ongoing infection
- Uncontrolled autonomic dysreflexia
- Complex regional pain syndrome
- Neurological degenerative diseases
- Peripheral nerve damage affecting the upper limbs
- Taking part in a conflicting research study
- People who are unable to tolerate TSCS during their first session
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal National Orthopaedic Hospital
London, HA7 4LP
Ufedo Miachi, 02089093780, ufedo.miachi@rnoh.nhs.uk
About this study
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Transcutaneous spinal cord stimulation added to inpatient rehabilitation, Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation
- Keywords
- Rehabilitation, Transcutaneous spinal cord stimulation, Upper limb
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulation added to inpatient rehabilitationOther
Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs
Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitationOther
Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust
| Study group | Role | What they receive |
|---|---|---|
| Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation | Active comparator | Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust Receives: Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation |
| Transcutaneous spinal cord stimulation added to inpatient rehabilitation | Experimental | Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust Receives: Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
Measured: 30 minutes
Secondary outcomes (8)
Modified Ashworth Scale (MAS)
This is a is a clinician-administered scale used to classify spasticity
Measured: 20 minutes
Range of Motion (ROM)
This is a is a clinician-administered scale used to classify the angles that can be achieved at each joint of the arm
Measured: 20 minutes
Electromyography (EMG) assessments
This will be assessed by researchers, and classifies the amount of muscle activity occurring during movements of the arms and hands.
Measured: 90 minutes
Individual goal planning
This is planned between the participant and their therapist, and defines what is important to the participant to gain from their rehabilitation
Measured: 20 minutes
Spinal Cord Independence Measure (SCIM)
This is a self-assessed outcome which asks the rater about 3 areas of function: self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and mobility
Measured: 30 minutes
Tetraplegic upper limb activity questionnaire (TUAQ)
This is a self-assessed questionnaire which is a self-assessment of hand and arm function
Measured: 30 minutes
International SCI data sets quality of life basic data set (SCI-QoL)
This is a self-administered short questionnaire which assesses quality of life
Measured: 15 minutes
Semi-structured interview
Participants will be asked to speak freely about their experience on this project and any recommendations they have for the team for future studies
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start28 Jun 2023
- Primary completion16 Apr 2028 (estimated)
- Study completion16 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Responsible party
- Sponsor
- Investigators
- Lynsey Duffell, PhD, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991804
- Sponsor's protocol ID
- 319893
- Acronym
- Up-Stim
- Status last verified
- Dec 2025
- First submitted
- 7 Aug 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the study is only 6 participants IPD will be provided in study publications.