Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement (Up-Stim)

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation; Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation

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 Type: Interventional
• Enrollment (Estimated): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joseph Steel, BSc; Phone Number: 02089095500; Email: joseph.steel@nhs.net
• Study Contact Backup: Name: Sarah Massey, PhD; Phone Number: 07713582559; Email: sarah.massey.13@ucl.ac.uk

Study Locations

• United Kingdom
  • London, United Kingdom, HA7 4LP
    • Recruiting
    • Royal National Orthopaedic Hospital
    • Contact: Ufedo Miachi; Phone Number: 02089093780; Email: ufedo.miachi@rnoh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcutaneous spinal cord stimulation added to inpatient rehabilitation; Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust	Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation; Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs
Active Comparator: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation; Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust	Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation; Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	This is a is a clinician-administered scale used to classify spasticity	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	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.	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	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	30 minutes
Tetraplegic upper limb activity questionnaire (TUAQ)	This is a self-assessed questionnaire which is a self-assessment of hand and arm function	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	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	60 minutes

Collaborators and Investigators

• Sponsor: University College, London
• Collaborators: Royal National Orthopaedic Hospital NHS Trust
• Investigators: Principal Investigator: Lynsey Duffell, PhD, University College, London

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2023
• Primary Completion (Estimated): April 16, 2028
• Study Completion (Estimated): April 16, 2028

Study Registration Dates

• First Submitted: August 7, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Rehabilitation; Upper limb; Transcutaneous spinal cord stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 319893

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the study is only 6 participants IPD will be provided in study publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No