RecruitingPHASE2, PHASE3INTERVENTIONAL

Non-Invasive Neuromodulation for Upper Extremity Function in Spinal Cord Injury: A Crossover Trial

This study is investigating two promising new treatments to help people who have a spinal cord injury in their neck area. The goal is to improve arm and hand function, which can make a big difference in daily life. Both treatments involve gentle, non-invasive electrical stimulation and physical exercises. Participants will try each treatment for two months, with a short break in between. We'll look at how safe they are, how well they work, and how they affect people's daily activities and quality of life. The study also aims to understand why some people respond better to one treatment over another, helping us to offer more personalised care in the future.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Alberta

Enrolment target

Start

07 May 2025

Estimated completion

31 Mar 2030

Spinal Cord Injury Cervical

What is this study about?

This research project is exploring two exciting new approaches to help people who have experienced a spinal cord injury in their neck. When the spinal cord is damaged in this area, it can make it difficult to move your arms and hands, which impacts everyday tasks and overall independence. The study aims to find better ways to help people get some of this movement back.

The two methods being tested are called 'transcutaneous spinal cord stimulation' and 'paired corticospinal-motoneuronal stimulation'. Don't worry about the long names! In simple terms, both involve placing small devices on the skin (non-invasive) to deliver very gentle electrical signals. These signals are thought to help 'wake up' and encourage connections between the brain and the injured spinal cord, improving how they communicate. Critically, both types of stimulation are always combined with regular exercises that focus on using the arms and hands.

The study is designed to compare these two treatments carefully. Each person taking part will try both treatments at different times, allowing us to see which one works best for them individually. We'll be looking at things like how much stronger your grip might become, how much easier it is to do daily tasks, and whether your overall quality of life improves. We also hope to learn if certain people respond better to one treatment than the other, which would help doctors decide who might benefit most from each therapy in the future. This could lead to more personalised and effective treatments for spinal cord injury.

Key takeaways

This study explores two gentle electrical stimulation therapies for arm and hand movement after spinal cord injury.
It aims to improve daily function and quality of life for people with neck-level spinal cord injuries.
You will try both treatments (stimulation + exercises) for two months each, with a break in between.
The study helps us understand which treatment works best for different individuals.
Participation involves regular therapy sessions and assessments over a few months.

Who may be eligible?

This study is looking for people who are aged between 18 and 75 years old. You must have had a spinal cord injury in your neck (from C2 to C8 levels). It needs to be an injury that happened because of an accident or trauma, and it must have happened at least nine months ago.

Your spinal cord injury should be classified as AIS A, B, C, or D. If you are taking medication for muscle spasms, your dose needs to be stable, meaning it hasn't changed recently. Both men and women can take part.

You cannot join if you have another injury to your nervous system apart from your spinal cord injury, or if you are pregnant. The researchers want to make sure the study focuses specifically on spinal cord injuries.

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 between 18 and 75 years old?
Did your spinal cord injury happen in your neck (C2-C8 area)?
Was your injury due to trauma, and did it happen more than 9 months ago?
Are you currently not pregnant?
Are you not taking unstable doses of anti-spasm medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll go through a few stages. First, you'll have some initial checks to make sure the study is right for you. Then, you'll be randomly assigned to start with either treatment A (transcutaneous spinal cord stimulation) or treatment B (paired corticospinal-motoneuronal stimulation).

You will receive your assigned treatment, combined with functional task practice (exercises), for two months. During this time, you'll have at least 12 treatment and exercise sessions per month, and can have up to 5 sessions a week if you're able to. After these two months, there will be a one-month break, called a 'washout period', where you won't receive either treatment. Following this break, you'll switch and receive the other treatment (the one you didn't have first) for another two months, again combined with exercises. Throughout the study, you'll have assessments to check your arm and hand strength, sensation, movement, and quality of life. The total time you'd be involved in the study is approximately five months.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as improvements in your arm and hand function, which could make daily tasks easier and improve your overall quality of life. However, it's important to remember that these are experimental treatments, and there's no guarantee you will experience any benefit. There might be some risks associated with the electrical stimulation, possibly including skin irritation or discomfort at the stimulation site, though these are typically mild and temporary. More serious side effects are rare. All procedures will be carefully monitored for your safety. You are free to withdraw from the study at any time, for any reason, without consequences for your future medical care.

Locations (1)

Glenrose Rehabilitation Hospital
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What does non-invasive mean?

Non-invasive means that nothing goes inside your body. The electrical stimulation is delivered through pads placed on your skin.

What kind of exercises will I do?

The exercises, called 'functional task practice', will focus on activities related to using your arms and hands for daily tasks, guided by therapists.

What is the purpose of the 'washout period'?

The one-month break (washout period) between treatments helps to ensure that any effects from the first treatment have faded before you start the second, so we can clearly see the effects of each individual treatment.

How often will I need to attend sessions?

You'll need to attend at least 12 sessions per month during each two-month treatment phase, and you can attend up to 5 sessions a week if you can.

Will I know which treatment I'm receiving at any given time?

Yes, you will know which of the two planned treatments you are receiving during each phase of the study.

How to find out more

Jessica M D'Amico, PhD

damico1@ualberta.ca 7802039478 Official trial record

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