Not yet recruitingNAINTERVENTIONAL

Spinal Stimulation With Gait Training to Improve Lower Limbs Motor Recovery in Spinal Cord Injury

This study is for people who have had a spinal cord injury within the last six months. During this time, the spinal cord is particularly ready to heal and learn new things. Researchers want to see if combining a special type of gentle electrical stimulation over the spine, called tSCS, with regular walking practice can help people regain movement in their legs more effectively than just walking practice on its own. The study will check if this combined approach is safe, possible to do in a rehabilitation setting, and if it leads to better leg movement. The hope is that stimulating the spinal cord during practice could boost muscle activity and improve walking abilities.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Enrolment target

Start

01 Jul 2026

Estimated completion

01 Jul 2029

Spinal Cord Injury Spinal Cord Injury Subacute Locomotion Gait Disorder, Sensorimotor Gait Disorders

What is this study about?

When someone has a spinal cord injury, it can make it very hard to move their body, especially their legs. But in the first six months after the injury, the spinal cord is often in a special state where it's more open to repairing itself and learning new ways to work. This is a really important time to try and help it recover as much as possible.

At the moment, rehabilitation centres mainly use 'activity-based therapy'. This means lots of intense practice doing movements and tasks to try and get the spinal cord working again. While this can help some people, it doesn't always fully restore movement, especially for walking.

This study is looking at a new idea: adding a gentle electrical stimulation to the spine, called tSCS, while people are doing their walking practice. This stimulation is given through pads on the skin over the spine. Some earlier studies in people who had their injury a long time ago suggested that this stimulation might help the spinal cord nerves work better and improve leg movement. Now, the researchers want to find out if this is also true, and safe, for people who are in the earlier, subacute phase (within 6 months) after their spinal cord injury. They think that by gently stimulating the spinal cord during walking practice, they might be able to 'wake up' the leg muscles more effectively and lead to greater improvements in movement.

Key takeaways

This study explores a new approach for people with recent spinal cord injuries.
It combines walking practice with gentle electrical stimulation on the spine.
The goal is to improve leg movement and walking ability.
Participation is for those injured in the last six months.
Researchers will check if the treatment is safe and effective.
You can withdraw from the study at any point.

Who may be eligible?

This study is looking for people who have had a spinal cord injury recently, specifically within one week to six months ago. You need to be at least 16 years old to take part.

Your injury must be located between the bones of your neck (C1) and your lower back (L2). You'll also need to be able to stand for at least 10 minutes, either on your own or with some help. You should be able to understand and follow instructions in either English or French.

There are also some reasons why you might not be able to join. For example, if you have a pacemaker, active cancer near where the stimulation would be, an unhealed wound or very bad pain that would stop you from having the pads placed on your skin. People who are pregnant, or have severe, ongoing nerve pain, or certain medical conditions or implants that might interfere with the treatment, also won't be able to participate.

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.

My spinal cord injury happened between 1 week and 6 months ago.
I am at least 16 years old.
I can stand for at least 10 minutes, with or without help.
I can understand and follow instructions in English or French.
I do not have a pacemaker or active cancer near my spine.
I am not pregnant.

Answer every question to see your result.

What does participation involve?

The detailed practical aspects of taking part, such as the number of visits, specific assessments, whether medication is involved, follow-up schedule, and the total expected duration of the study, are not fully described in the brief summary. However, based on the description, participation would involve regular gait (walking) training sessions. You would either receive active tSCS (the electrical stimulation) during these sessions or a 'sham' stimulation (which feels like stimulation but doesn't actually deliver therapy). You'd be expected to attend an intensive rehabilitation setting. The study would assess your limb movement before, during, and after the treatment period.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring and a new treatment approach that could potentially improve your leg movement more than standard therapy alone. However, there's no guarantee of improvement, and the tSCS is still being studied, so its effectiveness isn't fully known. Possible risks from the electrical stimulation might include skin irritation from the pads, or discomfort. You will always have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Institut de réadaptation Gingras-Lindsay-de-Montréal (IRGLM)
Verified postcode
Montreal, Canada

Common questions

What is 'subacute spinal cord injury'?

This means your spinal cord injury happened recently, specifically between one week and six months ago. It's a key time when your body is more ready to heal.

What is tSCS?

tSCS stands for transcutaneous spinal cord stimulation. It's a gentle electrical stimulation given through pads placed on your skin over your spine, designed to help stimulate the nerves.

What is 'gait training'?

Gait training is a type of exercise that focuses on helping you learn or relearn how to walk. It involves practising walking movements and activities.

Will this study definitely help me walk again?

No, there's no guarantee. This is a research study to see if combining these treatments is safe and might help, but individual results can vary greatly depending on your injury.

Can I stop participating in the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Dorothy Barthélemy, pht, PhD

dorothy.barthelemy@umontreal.ca 514-343-6111 Official trial record

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