University of Washington study finds new paralysis treatment restores use of hands

A new treatment that restores the use of paralyzed limbs is expected to be approved by the FDA this year.

Why it matters: The simple treatment could be life-changing for many of the 5.4 million Americans who live with paralysis, said lead researcher Chet Moritz, a professor at the Department of Rehabilitation Medicine at the University of Washington.

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State of play: Among 60 participants in a clinical trial of the device that provides electrical current to the spinal cord through electrodes on the skin, 72% saw significantly improved strength and function from using the treatment for two months, according to a UW study published in May in Nature Medicine .

How it works: Electrical stimulation of the spinal cord can restore impaired neurological function, according to the UW study.

• Prior devices were not designed to stimulate the spinal cord, and would have caused too much pain if they delivered levels of electrical current high enough to restore function, Moritz told Axios.
• The new device, manufactured by Netherlands-based Onward Medical , numbs the skin at the contact point with a very high frequency waveform that allows five times more electrical current to be delivered than in the past, he said.
• "That allows us to stimulate the motor neurons, which help to restore movement," Moritz said.

What they found: The study involved people with permanent arm and hand impairment from cervical spinal cord injuries that occurred between one and 35 years ago.

• Participants performed therapies and exercises while using the device.
• Almost three out of four patients demonstrated improvements in strength and function, with "significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life," per the study.
• There were no serious adverse impacts or side effects reported.
• "It is noteworthy that this study tested 60 people, which is a fairly large sample of people having a range of motor deficits due to spinal cord injury," said Douglas J. Weber of the Neuroscience Institute at Carnegie Mellon University.

Case in point: One participant, Jon Schlueter of Seattle, suffered an incomplete C5-C7 spinal cord injury as the result of a shallow diving accident in 2005 that left him with limited use of his arms and hands.

• Despite years of exercise-based rehabilitation, his gains were disappointing, he said in a UW Medicine article .
• After treatment with the Onward device, he saw immediate improvement and can now play the guitar .

What they're saying: "We've seen people that have no functional use of their hands at all go from not being able to pick up an object or manipulate an object all the way to being able to play an electric guitar or use a paintbrush on canvas," Moritz said.

• "We've also seen some people who had no movement of their fingers at all start moving them for the first time in more than a year since their injury."

A small panel on the shoulder lights up green when electrical impulses are delivered via a patch on the neck to the electrode at the patient's spinal injury site. Photo: Courtesy of UW Medicine

Yes, but: 28% of study participants did not see improvement, possibly due to the severity of their injuries, Moritz said.

What's next: FDA approval is expected later this year, according to Moritz. Initially, the device will be available by prescription and used in conjunction with skilled rehabilitation and occupational therapy.

• After that, it could be prescribed as part of a home exercise program.

What we're watching: International studies using a similar device to restore bladder function are ongoing, according to Moritz.