Father designs exoskeleton for his paralyzed son 1:21
(CNN) --
Michel Roccati lost the ability to walk after a motorcycle accident in 2017, when he suffered a complete spinal cord injury.
But today, equipped with an electrode device implanted in his spinal cord, Roccati can once again enjoy the simple things: standing up at a bar for a drink with his friends, showering without a chair, and even strolling around town in a walker. .
"I am free," says Roccati, who is Italian.
"I can walk wherever I want."
Roccati was one of three men between the ages of 29 and 41 who participated in the STIMO clinical trial, led by Dr. Jocelyne Bloch, from Lausanne University Hospital, and Grégoire Courtine, from the Swiss Federal Institute of Technology.
The results of the study were published Monday in the academic journal Nature Medicine.
Participants had 16-electrode devices implanted in the epidural space, an area between the vertebrae and the membrane of the spinal cord.
The electrodes receive currents from a pacemaker implanted under the skin of the abdomen.
All patients in the trial had a complete loss of voluntary movement below their lesions.
Two of them also had a complete loss of feeling.
But with the devices in place, the researchers were able to use a tablet to initiate unique sequences of electrical impulses, sent to the epidural electrodes via the pacemaker, to activate the participants' muscles.
This implant could make paralyzed people walk
Other studies have anecdotally looked at movement soon after surgery to implant similar devices, but this is the first study to report that all participants were able to take steps independently on a treadmill just one day after surgery, the researchers say. researchers.
advertising
Is there a relationship between education and public health?
2:23
"It's a very emotional moment, because [patients] realize they can take steps," Bloch said.
Researchers have been studying electrical stimulation of the spinal cord for three decades.
This study redesigned the technology originally used for pain relief to target the spinal nerve roots.
Earlier studies from the University of Louisville showed that people who were completely paralyzed but still had feeling could walk again with several months of rehabilitation using electrical stimulation of the spinal cord.
In the STIMO trial it was found that one week after the operations, all three participants were able to walk independently with body weight support on parallel bars and an overhead harness.
"For the first time, not only do we have an immediate effect, although training is still important, but individuals who lost sensation, without any movement, have been able to fully regain standing and walking independent of the lab," Courtine told CNN. .
Dr. Nandan Lad, a neurosurgeon at Duke University, said this "exciting work offers a new treatment option for tens of thousands of patients who have spinal cord injuries and really have no other options."
Lad leads a clinical trial in this area of research in the US and was not involved in the new study.
A study reveals the impact that 10 minutes of exercise can have on adults over 40
The Swiss team was able to record immediate results thanks to important changes in the structure and implantation of their electrode device.
The electrode array used in the STIMO trial, manufactured by Onward Medical, is wider and longer than that commonly used in similar studies.
According to Bloch, this new electrode array allows access to a larger area of the spinal cord to stimulate the muscles of the trunk and legs.
The researchers developed an algorithm to optimally position the electrode array, performing tests during surgery to measure muscle activity after delivering the pulses.
Precise neurosurgical placement of the electrodes is the key to the study's ability to stimulate needed muscle groups in the legs so quickly, Lad said.
What is the best cancer treatment?
4:49
The STIMO trial also introduces a new method for initiating and maintaining movement.
To initiate stimulation, previous studies relied on the participants' intention to move and the brain signals that followed.
In the new study, a timed sequence of stimulations is generated using motor responses to different jolts of electricity.
These preset sequences trigger movement and attempt to mimic the natural pattern of muscle activation necessary for walking.
Susan Harkema, a professor in the Department of Neurological Surgery who led the Louisville studies, said it's encouraging to learn that two types of stimulation can drive movement patterns through the circuitry of the human spine, indicating that some function is preserved. , even with total injuries.
"But I don't think we have enough evidence yet to know what the best way to stimulate is to get the best results," Harkema told CNN.
CAR-T Cell Therapy Achieves 10-Year Remission in Two Leukemia Patients: Study
With the STIMO device, people with total spinal cord injuries can regain voluntary leg movement only while receiving stimulation.
While the device is off, voluntary movement will not be possible.
The electrodes can stay in place for life, but the pacemaker must be replaced every nine years.
However, with training, patients can increase their endurance and perform a broader range of activities.
After the operation, study participants received one to two hours of physical therapy four times a week.
With three or four months of constant training, one of the participants could stand for two hours at a time.
Another could walk 500 meters independently.
One participant even climbed stairs again.
The tablet used in the study comes equipped with specific programs coded for certain types of activity, such as standing, walking and swimming.
Ivermectin, not recommended treatment against covid-19 5:00
"The more they train, the more they get done, so they need motivation to be able to stay on their feet for a long time," Bloch said of the participants' progress.
Study finds which male pattern baldness treatment works best
Courtine and Bloch now plan to work with Onward Medical to make the device easier to use on a day-to-day basis, such as integrating the program with cell phones or smart watches.
The team then wants to scale up to conduct a larger clinical trial in the United States.
They estimate that it will take another three to four years for the technology to become commercially available.
At a press conference last week, the researchers announced that the US Food and Drug Administration (FDA) has approved a "breakthrough device" designation to speed up the process.
This designation would also guarantee coverage through Medicare's Innovative Technology Coverage program if larger clinical trials are successful.
"I think [this research] should be an appeal to all of us to understand that there is hope for treating these patients," said Dr. Nicholas Theodore, director of the Johns Hopkins Spine Neurosurgical Center, who was not involved in the study. research.
"I think the hope right now is going to be through an engineering solution and less of a cell repair strategy."
ParalysisTreatment