Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Transcutaneous spinal cord stimulation added to inpatient rehabilitation
* Other: Inpatient rehabilitation alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inpatient rehabilitation alone<br>Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust | Other: Inpatient rehabilitation alone<br>* Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust<br>|
| Experimental: Transcutaneous spinal cord stimulation added to inpatient rehabilitation<br>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<br>* Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Transcutaneous spinal cord stimulation, Upper limb