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

University College London (UCL)

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation; Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05991804

319893

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation

Active Comparator group

Description:

Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust

Treatment:

Other: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation

Transcutaneous spinal cord stimulation added to inpatient rehabilitation

Experimental group

Description:

Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust

Treatment:

Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation