Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2028-04-16

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.

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.

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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 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.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

Sham transcutaneous spinal cord stimulation (placebo) added to Standard inpatient rehabilitation given at the Royal National Orthopaedic Hospital NHS Trust

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

Group Type EXPERIMENTAL

Transcutaneous spinal cord stimulation added to inpatient rehabilitation

Intervention Type OTHER

Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs

Interventions

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Transcutaneous spinal cord stimulation added to inpatient rehabilitation

Non-invasive electrical stimulation delivered over the spine, targetting movement of the upper limbs

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No