by Kim Anderson, PhD
You may have heard talk over the past six months about a new therapy getting approved for people living with a cervical spinal cord injury (SCI). You may have questions. We have answers.
On December 12, 2024, the Food and Drug Administration (FDA) approved the ARC-EX System for use in the US. It is the first system approved by the FDA for non-invasive spinal cord stimulation specifically for SCI.
What is ARC-EX?
ARC-EX is the name of a device that delivers transcutaneous electrical stimulation to the spinal cord. You may have heard of functional electrical stimulation (FES). FES is when electrical stimulation is delivered to a muscle by putting sticky pads (electrodes) on the skin. The stimulation triggers the nerves in the muscle to contract even if you cannot move the muscle voluntarily. Transcutaneous electrical stimulation is similar but different from FES. Sticky pads are placed on the skin like FES, but the pads are placed over the spinal cord instead of a muscle. The stimulation triggers activation of the spinal cord of movements that you already have control over, even if it is very weak control; that is a key difference from FES. As a result, transcutaneous electrical stimulation must be used in combination with physical therapy targeting those voluntary movements. By doing these together, it gets easier to make the movements.
Who can use ARC-EX?
In order to obtain FDA approval, a clinical trial called Up-LIFT was done. This trial enrolled 65 participants and was used to decide who was eligible for ARC-EX, what improvements can occur, and the safety profile. Most importantly, ARC-EX is very safe. There were no bad side effects due to the device or therapy. People that can get ARC-EX must have an SCI in the neck region (anywhere between cervical level 2 through 8). They also must be between the ages of 18 and 75 and have an ‘ASIA’ grade of B, C, or D. People also must have a chronic SCI, which is usually thought of as being at least 1-year post-injury. One important factor dictating who cannot use the system is if you already have an implanted medical device like a heart pacemaker or defibrillator or a baclofen pump. That is because the stimulation might interfere with the implanted device.
What are the benefits of ARC-EX?
As mentioned above, ARC-EX needs to be used together with hand therapy. The dose that seems to work well is 1 hour per day given 3 days per week. In the clinical trial, people received the combination therapy over a 2 month period. Some people saw immediate effects, but often times it takes a few sessions over days or weeks before seeing changes. In the clinical trial, 90% of the participants improved in at least 1 measure of strength or function – examples of these gains in real life include picking up a cup full of liquid, pushing a button on a remote, stabbing food with a fork, button a shirt, typing, etc. Also, 87% of the participants reported an improvement in the quality of life. Some participants, not all, reported having fewer spasms, better sleep, and improved feeling in the upper body, especially in light touch. Additionally, some people needed less help from caregivers to do daily tasks and some people found that they were able to do things by themselves faster or with less effort.
The benefits people gained do last after the therapy finishes, but they do lessen gradually over time. It seems that continued therapy or practice may need to occur periodically. More research is needed to determine how frequently people may need to repeat ARC-EX with therapy in order to maintain persistent gains.
Where can you get ARC-EX?
Currently, it is only available in clinics that are licensed to provide rehabilitation in the US. The clinic purchases the device and can administer therapy for up to 50 people per device. An individual just needs to be determined as eligible to receive therapy. Insurance coverage may influence how much therapy a person can get, as usual. The company is working to get FDA approval for in-home use followed by insurance coverage for home devices, then they will work on getting approval in other countries. The company is also currently ramping up production and field support to be able to service as many clinics as possible across the US. Sometime this year a ‘clinic finder’ tool will be available on their website.
The MetroHealth Rehabilitation Institute has begun discussions with the company to obtain an ARC-EX system. We are developing an internal process to be able to offer this as a rehabilitation service in the outpatient clinic. Stay tuned for more news on when that will be available.
Where can you learn more?
There are several resources available for you to learn more about ARC-EX and the Up-LIFT clinical trial.
- Onward Medical website https://www.onwd.com/
- Short overview video of how ARC-EX works https://www.youtube.com/watch?v=3ZaFXKcybnA
- Christopher and Dana Reeve Foundation webinar about ARC-EX and Up-LIFT https://www.youtube.com/watch?v=yGzvwYjH8qg
- New Mobility article https://newmobility.com/onward-transcutaneous-stimulation-device-offers-functional-return-after-sci/
- Scientific article about Up-LIFT https://www.nature.com/articles/s41591-024-02940-9
