Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

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.

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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