RecruitingNAINTERVENTIONAL

Noninvasive Spinal Cord Stimulation for Early SCI

This study is investigating a new, non-surgical treatment called SCONE™ (Spinal COrd NEuromodulation) for people with spinal cord injuries (SCI). SCONE™ uses gentle electrical pulses delivered through the skin to the spine. Researchers want to see if this stimulation can help improve bladder, bowel, and sexual function, as well as reduce muscle stiffness and improve overall quality of life for people with SCI. The study involves two groups. One group gets the active stimulation along with their usual rehabilitation, while the other group gets a 'sham' (inactive) stimulation at first, then switches to the active treatment. It's taking place in Canada and Ukraine, and aims to see if this treatment is safe and effective in promoting recovery.

At a glance

Status

Recruiting

Phase

Sponsor

University of British Columbia

Enrolment target

Start

01 Oct 2024

Estimated completion

01 Oct 2027

Spinal Cord Injuries Bowel Dysfunction Sexual Dysfunction Autonomic Dysfunction Urologic Disorders

What is this study about?

This research study is looking into a new treatment called SCONE™ (Spinal COrd NEuromodulation). This treatment involves placing special pads on your skin over your spine that deliver gentle electrical pulses. The idea is that these pulses can help to 'wake up' and retrain the nerves in your spinal cord that control important body functions. The main goal is to see if this stimulation can help people with spinal cord injuries improve problems they might have with their bladder, bowel, and sexual function. Doctors also want to see if it helps with muscle stiffness and generally improves quality of life.

The study is designed to see if the SCONE™ treatment is safe and effective. It's a 'Phase II' study, which means it builds on earlier research that showed the treatment was safe. Researchers will compare people who receive the active SCONE™ treatment with those who get a 'sham' treatment, which looks and feels similar but doesn't deliver the active stimulation. This helps them understand if any improvements are truly due to the SCONE™ device or other factors.

Ultimately, the results of this study could lead to a new, non-surgical way to help people with spinal cord injuries regain more control over their bodies and live more comfortably. If successful, it could offer a valuable alternative or addition to current rehabilitation methods.

Key takeaways

Investigating a non-surgical electrical stimulation for spinal cord injury.
Aims to improve bladder, bowel, and sexual function, plus reduce muscle stiffness.
Involves 8 to 16 weeks of treatment alongside regular rehabilitation.
Participation lasts about 33 weeks with regular visits.
Includes a comparison to a 'sham' (inactive) treatment initially.

Who may be eligible?

To be considered for this study, you need to be an adult between 19 and 65 years old. You must have a spinal cord injury, either fairly recent (3-6 months ago) or longer-term (12 months or more ago). Your injury should be of a certain type (AIS A or B, between sections C5 and T10 of your spine) and you must have documented bladder problems.

There are also some important points about women who could become pregnant and men with partners who could become pregnant. If you are a woman who could get pregnant, you must not be planning to become pregnant, currently pregnant, or breastfeeding. You'll need a negative pregnancy test before starting and agree to use effective birth control during and for a short time after the study. Men with female partners who could become pregnant also need to agree to use effective birth control.

You can't join the study if you have severe depression or PTSD, or have had certain types of bladder surgery. Your injury also shouldn't affect the very bottom part of your spinal cord unusually. You'll need to live in British Columbia, Canada, or Ukraine to participate, and be willing to attend all study visits and follow the guidelines on your bowel and bladder routines and medications.

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 19 and 65 years old?
Do you have a spinal cord injury that happened at least 3 months ago?
Do you experience bladder problems?
Are you able to attend all 58 study visits over 33 weeks?
Do you live in British Columbia, Canada or Ukraine?

Answer every question to see your result.

What does participation involve?

If you join this study, it will involve quite a few visits – 58 visits in total – stretched out over about 33 weeks (just over 7 months). During this time, you will receive either the active SCONE™ stimulation or a 'sham' (inactive) stimulation as part of your treatment.

If you are in the active treatment group, you'll have 8 weeks of SCONE™ therapy three times a week, for one hour per session. This will be alongside your regular rehabilitation, which is usually 3-4 hours a day, five days a week. If you are in the sham group first, you'll have 8 weeks of sham stimulation with your regular rehab, and then you'll switch to 8 weeks of the active SCONE™ treatment. The first group will continue with active treatment for another 8 weeks after the initial period.

Throughout the study, there will be various assessments to see how your bladder, bowel, sexual function, muscle stiffness, and quality of life are changing. You'll also have follow-up visits to track your progress.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that the SCONE™ treatment could improve your bladder, bowel, and sexual function, reduce muscle stiffness, and enhance your overall quality of life. This is new research, so there's no guarantee the treatment will work for everyone, or at all. Potential risks associated with electrical stimulation through the skin are generally mild, such as temporary skin irritation where the pads are placed. The researchers will carefully monitor you for any side effects. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Blusson Spinal Cord Centre
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is SCONE™?

SCONE™ is a new device that delivers gentle electrical pulses through pads on your skin, over your spine, to stimulate nerves associated with bodily functions like bladder control.

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

Initially, you won't know if you're getting the active SCONE™ treatment or a 'sham' (inactive) stimulation. This helps researchers get clear results, but after 8 weeks, everyone will receive the active treatment.

How long will I be involved in the study?

If you join, your participation will last about 33 weeks (around 7.5 months), including treatment sessions and follow-up appointments.

What body functions does this study hope to improve?

The main focus is on improving bladder function, but researchers are also looking at bowel and sexual function, muscle stiffness, and overall quality of life.

Where is the study happening?

The study is taking place in two locations: Vancouver, Canada, and Rivne, Ukraine.

How to find out more

Andrea Maharaj, BSc

amaharaj@icord.org 604.675-8856 Official trial record

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