RecruitingPHASE2, PHASE3INTERVENTIONAL

Transcutaneous Spinal Cord Stimulation for Upper Extremity Function

This research is looking into a treatment called transcutaneous spinal cord stimulation (tcSCS) to help people regain movement in their arms and hands after a spinal cord injury or stroke. This method uses small electrical currents delivered through the skin to gently stimulate the spinal cord. We know that similar but more invasive treatments have shown promise. However, we need to understand more about how tcSCS works best, like where to place the stimulation pads and what type of electrical pattern to use, to get the most benefit. The study will also see if this non-invasive method can help stroke survivors, which hasn't been fully explored. Our goal is to make this promising treatment as effective as possible to improve daily life for those affected.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

University of Alberta

Enrolment target

Start

15 Jun 2024

Estimated completion

30 Dec 2029

Spinal Cord Injuries Stroke

What is this study about?

Imagine a gentle, electrical 'buzz' on your skin that could help your injured arm or hand move better. That's the basic idea behind a treatment called transcutaneous spinal cord stimulation (tcSCS). This study is exploring how this non-invasive (meaning it doesn't involve surgery) treatment can help people who have had a spinal cord injury or a stroke to improve their arm and hand function.

We know that the brain and spinal cord connect to control movement. When there's an injury, these connections can be disrupted. TcCS works by sending mild electrical signals through sticky pads placed on your skin over your spine. These signals are thought to 'wake up' and strengthen the remaining pathways in your spinal cord, helping your brain communicate better with your muscles. While similar, more invasive treatments have shown good results, we still don't fully understand the best ways to use this simpler, non-invasive method.

This research aims to answer important questions: What are the best settings for the stimulation (like where on the back to place the pads and how often to send the signals)? How do these settings change the way your nervous system works? And importantly, does combining this stimulation with physical therapy lead to real, lasting improvements in arm and hand movement for people with spinal cord injuries and stroke? By finding these answers, we hope to make tcSCS a more effective tool to help people regain independence and improve their quality of life.

Key takeaways

This study explores a non-invasive (no surgery) treatment for arm/hand movement.
It uses gentle electrical stimulation over the spine for spinal cord injury and stroke.
The goal is to find the best ways to use this treatment for better recovery.
Participation involves stimulation sessions, physical therapy, and various assessments.
It may help improve arm and hand function, but results can't be guaranteed.
You can stop participating at any time.

Who may be eligible?

To be considered for this study, you generally need to be between 18 and 75 years old. If you've had a spinal cord injury (SCI), it needs to be in your neck area (C3 to C8) and have happened at least one year ago. If you've had a stroke, it needs to have affected your arm and hand movement at least six months ago, and you should still have some movement in your arm.

There are some reasons you might not be able to participate. You can't be pregnant. You also can't have severe problems with speaking or understanding language. If you have very stiff muscles (spasticity) that are rated as a 3 or higher on a specific scale, this study might not be suitable for you.

Also, if you have any metal implants in your head or body, like a pacemaker, a deep brain stimulator, or even some dental implants, this study might not be right for you. This is because a part of the study involves a test called transcranial magnetic stimulation (TMS), which uses magnets. If you've ever had seizures or epilepsy, or if you're taking any medication that could make you more prone to seizures, you also wouldn't be able to take part.

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?
If you had a spinal cord injury, was it at your neck level (C3-C8) and at least 1 year ago?
If you had a stroke, was it at least 6 months ago and did it affect your arm/hand with some movement remaining?
Are you not pregnant?
Do you not have severe speech or understanding problems?
Do you not have a pacemaker, deep brain stimulator, or other metal implants besides standard dental fillings?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will be split into a few parts. Firstly, we will explore how different stimulation settings (where we place the pads and the type of electrical signal) affect your nervous system. We will use special tests to measure this. Then, for a period, you will take part in an intervention phase. This involves combining the transcutaneous spinal cord stimulation with regular physical therapy exercises aimed at improving your arm and hand function.

Throughout the study, we will conduct assessments to see how your arm and hand movement is improving. These will include clinical tests where we measure your abilities, and neurophysiological assessments which look at how your nerves and muscles are working. This research is divided into two main stages (Phase 2 and Phase 3). The total length of your participation will depend on which stage you are involved in and what specific parts apply to you. If you are taking certain medications for muscle spasms, their dose and how often you take them must have been stable for at least 4 weeks before you start the study. Specific details about the number of visits, their duration, and follow-up will be discussed in full if you are considered for the study.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to a better understanding of how non-invasive treatments can help people recover arm and hand function after a spinal cord injury or stroke. While direct personal improvement in your arm and hand function is hoped for, it cannot be guaranteed. As with any medical research, there are potential risks. The electrical stimulation used is generally safe, but you might experience some skin irritation where the pads are placed, or mild discomfort during the stimulation. The transcranial magnetic stimulation (TMS) part of the study carries a very small risk of seizures, especially if you are prone to them, which is why we have strict exclusion criteria. You will be monitored closely for any side effects. Remember, joining any research study is completely voluntary, and you have the right to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (2)

Glenrose Rehabilitation Hospital
Verified postcode
Edmonton, Canada· Recruiting
University of Alberta
Verified postcode
Edmonton, Canada· Recruiting

Common questions

What does 'transcutaneous spinal cord stimulation' mean?

It's a non-surgical treatment where mild electrical currents are sent through sticky pads on your skin, over your spine, to gently stimulate your spinal cord. 'Transcutaneous' means 'through the skin'.

Is this treatment painful?

Most people feel a tingling or buzz rather than pain. We adjust the level to make sure you are comfortable.

Will this cure my condition?

This study aims to improve arm and hand movement, but it's not expected to be a cure. We are hoping to find better ways to help with recovery.

Are there any long-term side effects?

Serious long-term side effects from this type of stimulation are rare, but we will monitor you closely during and after the study for any effects.

Can I continue my regular medications?

Yes, but if you take medicines for muscle spasms, the dosage must have been stable for at least 4 weeks before starting the study.

How to find out more

Jessica D'Amico, PhD

damico1@ualberta.ca 7807357917 Official trial record

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