RecruitingNAINTERVENTIONAL

Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement

This study aims to improve arm and hand movement for people with spinal cord injuries. In the UK, many people each year suffer these injuries, and improving arm function is a top priority as it greatly impacts daily life. Researchers are investigating whether adding a gentle electrical stimulation to the neck (called Transcutaneous Spinal Cord Stimulation or TSCS) during standard rehabilitation helps more than rehab alone. This small study will compare TSCS with a dummy treatment (placebo) to see if it can boost recovery and reduce muscle stiffness in the arms. If successful, this could be a simple and affordable way to help people regain independence.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

28 Jun 2023

Estimated completion

16 Apr 2028

Spinal Cord Injuries

What is this study about?

Each year in the UK, over 1000 people experience a spinal cord injury. About half of these injuries affect the neck area, which can lead to difficulties with arm and hand movement. For people with these types of injuries, called tetraplegia, regaining even a little bit of movement in their arms and hands is extremely important. It can make a huge difference to everyday activities like eating, dressing, or writing, and greatly improve independence and quality of life.

This study is exploring a new approach during rehabilitation called Transcutaneous Spinal Cord Stimulation (TSCS). This involves placing small pads on the skin of the neck to deliver a very gentle electrical current to the spinal cord. The idea is that this stimulation, when combined with standard rehabilitation exercises, might help to wake up and strengthen the connections involved in arm and hand movement. Researchers want to see if this can lead to better arm control, improved strength, and less muscle stiffness (spasticity) compared to rehabilitation on its own.

This is a 'feasibility study', which means it's a smaller, early-stage study to check if the treatment is practical and effective. Some participants will receive the actual TSCS treatment during their rehabilitation, while others will receive a 'sham' treatment. The sham treatment will feel similar but won't deliver the active electrical current, acting as a comparison. This helps the researchers understand if any improvements are due to the TSCS itself or other factors related to being in a study.

Key takeaways

This study evaluates gentle electrical stimulation for arm and hand recovery after spinal cord injury.
It aims to improve daily activities and independence.
Participation involves receiving either active or dummy stimulation during inpatient rehab.
There will be follow-up assessments to track progress up to one year post-injury.
It's an early-stage study to see if this treatment is practical and effective.

Who may be eligible?

To join this study, you must be 18 years old or over and have recently had a spinal cord injury. You need to be an inpatient at the Royal National Orthopaedic Hospital (RNOH) and your injury should affect the neck area (levels C1 to C8).

There are some reasons why you might not be able to take part. For example, if you are pregnant, planning to become pregnant, or breastfeeding. Also, if you have a heart pacemaker, certain medical conditions like some auto-immune disorders, ongoing infections, or other problems with your arms or spine, you would not be able to join.

Finally, if you can't comfortably tolerate the gentle electrical stimulation during an initial test session, or if you are already involved in another conflicting research study, you wouldn't be eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you recently had a spinal cord injury and are you an inpatient at RNOH?
Does your injury affect your neck area (C1-C8 levels)?
Are you not pregnant, planning pregnancy, or breastfeeding?
Do you not have a heart pacemaker?
Can you comfortably tolerate mild electrical stimulation on your skin?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a short test to see if you can comfortably tolerate the harmless electrical stimulation. If you're comfortable, you would then be randomly assigned to one of two groups: either receiving the real electrical stimulation (TSCS) or a dummy stimulation (sham TSCS). Both groups will receive this alongside their usual inpatient rehabilitation at the RNOH.

Throughout your time as an inpatient, the research team will carry out regular assessments. Some of these are part of your standard care, and others are extra assessments specifically for the study to check your arm and hand function. After you leave the hospital, you'll have an interview to talk about your experience. You will then be invited back to the RNOH for two follow-up appointments: one about 6 months after your injury and another one year after your injury. These follow-up sessions will repeat the assessments to see how you are progressing.

Potential risks and benefits

Potential benefits of taking part could include improved arm and hand function, which might make daily tasks easier and increase your independence. However, there's no guarantee that you will personally benefit. Potential risks are generally low, as the electrical stimulation is gentle and non-invasive. Some people might experience mild skin irritation where the pads are placed. You are free to withdraw from the study at any time, for any reason, without it affecting your care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal National Orthopaedic Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'Transcutaneous Spinal Cord Stimulation' (TSCS)?

It's a gentle electrical current delivered through pads on your skin, usually on the neck, to help stimulate the spinal cord and improve arm movement.

Will I know if I'm getting the real treatment or the dummy treatment?

No, you won't know. This is called a 'blinded' study and helps researchers fairly assess the true effects of the treatment by comparing it to a placebo (dummy treatment).

How long will I be in the study?

You'll take part during your inpatient rehabilitation, and then you'll have two follow-up appointments at 6 months and 1 year after your injury.

What happens if I want to stop taking part?

You can withdraw from the study at any time without having to give a reason, and it will not affect the medical care you receive.

Who is running this study?

The study is being run by researchers at the Royal National Orthopaedic Hospital (RNOH) in the UK.

How to find out more

Joseph Steel, BSc

joseph.steel@nhs.net 02089095500 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.