Not yet recruitingNAINTERVENTIONAL

Upper Limb Rehabilitation Using Non-invasive Spinal Cord Stimulation

This study aims to find out if combining regular exercises with a gentle electrical stimulation applied to the skin (called tSCS) helps people with a recent spinal cord injury in their neck recover better use of their arms and hands. Researchers want to see if this combination improves movement more than just exercises alone. They will also look at changes in the brain and spinal cord, and if people feel they can use their arms more in everyday tasks. Participants will do 20 exercise sessions over about six to eight weeks, either with the real electrical stimulation or a practice (sham) one, and will have some tests at the start, during, and after the study.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

Enrolment target

Start

01 Apr 2026

Estimated completion

09 Aug 2028

Spinal Cord Injury Cervical Spinal Cord Injury, Acute Spinal Cord Injury (Quadraplegia)

What is this study about?

This study is looking into new ways to help people who have had a spinal cord injury, specifically in the neck area. When someone has this type of injury, it can affect their ability to move their arms and hands. The researchers want to see if a special treatment can improve this.

They are focusing on something called "Activity-Based Therapy" (ABT), which involves different exercises like strengthening, practicing daily tasks, and even imagining movements. They are combining this with a gentle electrical stimulation applied to the skin over the spinal cord, called transcutaneous spinal cord stimulation (tSCS). The main idea is to find out if this combination helps people recover more movement in their arms and hands compared to just doing the exercises alone. They also want to understand if this treatment changes how the brain and spinal cord work, and if it helps people use their arms better in their everyday lives.

This research is important because it could lead to better ways to help people regain independence after a spinal cord injury. By understanding if and how this combined approach works, doctors might be able to offer more effective rehabilitation treatments in the future.

Key takeaways

Tests a combination of exercises and gentle electrical stimulation for arm recovery.
Aims to improve arm/hand movement and daily activities after neck spinal cord injury.
Involves 20 training sessions over 6-8 weeks.
Participants will have assessments at three points to track progress.
You might receive real or 'sham' electrical stimulation.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be at least 16 years old and have had a spinal cord injury in your neck, typically within the last few months (between one week and six months ago). Your injury level must be above the T2 vertebra, and you should be staying at the Institut de réadaptation Gingras-Lindsay de Montréal, Canada.

You also need to have some remaining movement in your upper limbs and your injury should be classified as ASIA A to D. It's important that you can understand and follow instructions in either French or English, and you must be able to give your informed consent, meaning you understand what the study involves and agree to take part.

There are also some reasons why you might not be able to join. For example, if you have a pacemaker, have active cancer in the area where the stimulation would be applied, or have very unstable health. Also, if you have unhealed wounds or severe pain that would make it impossible to place the electrical pads, you couldn't participate. If you have conditions like epilepsy or unhealed head fractures, you might still be able to join, but you wouldn't be able to have certain brain activity tests (called TMS and EEG).

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 at least 16 years old?
Did you have a neck spinal cord injury (above T2) between 1 week and 6 months ago?
Do you have some remaining movement in your arms or hands?
Are you currently receiving care at the Institut de réadaptation Gingras-Lindsay de Montréal?
Can you understand and follow instructions in English or French?
Do you not have a pacemaker or active cancer at the stimulation site?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be put into one of two groups by chance: either you'll receive activity-based exercises with the real electrical stimulation (tSCS), or you'll get the same exercises with a 'sham' (pretend) stimulation, which feels like a very low tingle but doesn't have the same effect. You won't know which group you are in, and neither will the therapists delivering your treatment.

You will attend 20 training sessions over about 6 to 8 weeks, with three sessions each week. Each session will involve 45 minutes of active training with a therapist. These exercises will include mental imagery, warm-ups, stretches, strength training, and activities related to daily life.

Before you start, after you complete the training, and then again one month later, you'll have some clinical tests and special assessments to measure your arm and hand recovery and look at brain activity. These tests include checking your movement and feeling, and some special ways to look at your brain and spinal cord signals. The total duration of your active involvement in the study will be around 2 to 3 months.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improved arm and hand function through the intensive activity-based therapy, possibly enhanced by the electrical stimulation. However, there's no guarantee of personal benefit, and individual results can vary. Potential risks from the electrical stimulation are generally mild and might include slight skin irritation where electrodes are placed, or some discomfort, though serious side effects are rare. Some of the assessments involve small electrical or magnetic pulses to measure brain activity, which are generally safe but may involve minor sensations. You are always free to withdraw from the study at any time without having to give a reason, and this will not affect your future medical care.

Locations (1)

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

Common questions

What is 'spinal cord stimulation'?

It's a gentle electrical current applied to the skin over your spinal cord, designed to help activate nerves and muscles in your arms and hands.

What is 'Activity-Based Therapy'?

It's a type of exercise program that includes strengthening, practicing daily tasks, stretches, and even imagining movements to help you regain function.

Will I know if I'm getting the real stimulation or the 'sham' one?

No, you won't know, and neither will the therapists. This helps make sure the study results are fair and accurate.

How long will I be involved in the study?

You'll have training sessions for about 6-8 weeks, and then a follow-up assessment one month later, so your active participation will span about 2-3 months.

Can I stop participating in the study if I want to?

Yes, you can leave the study at any time for any reason, and it will not affect your medical care.

How to find out more

Dorothy Barthelemy, pht., Ph.D

dorothy.barthelemy@umontreal.ca +1 514-343-6111 Official trial record

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