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
- Are there results?
- Not yet: the study is under way
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
Show all 14Show fewer
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
- ClinicalTrials.gov ID
- NCT05991804
- Acronym / sponsor ID
- Up-Stim / 319893
- Conditions
- Spinal Cord Injuries
- Keywords
- Rehabilitation, Transcutaneous spinal cord stimulation, Upper limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Royal National Orthopaedic Hospital NHS Trust
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 16 Apr 2028 (estimated)
- Study completion
- 16 Apr 2028 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation | Active comparator | Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitationStandard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust |
| Transcutaneous spinal cord stimulation added to inpatient rehabilitation | Experimental | Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitationTranscutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulation added to inpatient rehabilitationNon-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs | Other | Transcutaneous spinal cord stimulation added to inpatient rehabilitation |
| Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitationSham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust | Other | Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation |
Primary outcome
Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
Time frame: 30 minutes
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
8 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: 20 minutes
Range of Motion (ROM)
Time frame: 20 minutes
Electromyography (EMG) assessments
Time frame: 90 minutes
Individual goal planning
Time frame: 20 minutes
Spinal Cord Independence Measure (SCIM)
Time frame: 30 minutes
Tetraplegic upper limb activity questionnaire (TUAQ)
Time frame: 30 minutes
International SCI data sets quality of life basic data set (SCI-QoL)
Time frame: 15 minutes
Semi-structured interview
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No. As the study is only 6 participants IPD will be provided in study publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lynsey Duffell, PhD principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Steel, BSc (02089095500, joseph.steel@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Standards of Neurological Classification for SCI (ISNC-SCI). (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.