Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement — Up-Stim  

Spinal Cord Injuries Clinical Trial

Official title: Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Status Recruiting

Clinical 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 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.

We are investigating the effect of adding non-invasive SCS to inpatient rehabilitation on upper limb function for people with acute SCI. We will test this by randomly assigning volunteers to either a control group, who will receive their normal inpatient rehabilitation only, and an intervention group, who will have non-invasive SCS added to their normal inpatient rehabilitation, targeting their upper limbs.

Clinical Trial 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 into either the control group, where they will receive their standard inpatient rehabilitation only, or into the intervention group, where they will have non-invasive SCS added to their inpatient rehabilitation, targeting the arms and hands.

For both the control 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).

After participants have been discharged from the RNOH, we will contact you to do some follow-up assessments, which can be done at home or over the phone. There will be 2 follow-up assessments, the first will be done at 6-months post-injury, and the second will be done at 1-year post-injury. If participants are already 6-months post-injury at discharge, then the first follow-up assessment will be done at 1-month post-discharge, and the second at 1-year post-injury. The follow-up assessments will be the TUAQ, and the SCI-QoL. ;

Related Conditions & MeSH terms

• Spinal Cord Injuries

• NCT number: NCT05991804
• Study type: Interventional
• Source: University College, London
• Contact: Joseph Steel, BSc
• Phone: 02089095500
• Email: joseph.steel@nhs.net
• Status: Recruiting
• Phase: N/A
• Start date: June 28, 2023
• Completion date: April 16, 2025