Once relegated to fiction, implanted microelectronics will restore function to spinal injury survivors.
“We can rebuild him. We have the technology.” What was science fiction in the 1970s television series “The Six Million Dollar Man” may be about to become very real.
Scientists have developed implantable technology that could allow people with spinal injuries to move their muscles using their own brainwaves.
Neuroprosthetics developed at Case Western Reserve University (CWRU) are now on the fast track to move from the laboratory into manufacturing and human testing.
If all goes well, the devices could be on the market in 2017.
“We are very excited about what we’re getting ready to do. There’s lots of forward momentum,” Megan Moynahan, executive director of the university’s Institute for Functional Restoration, told Healthline.
The fully implantable system uses neurostimulation to restore muscle function in paralyzed patients.
Earlier work at CWRU created components outside the body that allowed paralyzed individuals to grasp and drink from a cup, maintain balance, breathe and cough, regain bladder control, and stand.
Electrical stimulation uses neural pathways and creates or restores motion. Surgeons can embed an entire customized system under the skin, thanks to smaller, more powerful and longer-lasting batteries and microelectronics. Patients recharge the battery each night using a wireless charger.
A lot of work in recent years has been devoted to restoring function to people with spinal cord injuries or other debilitating conditions.
Last year, National Institutes of Health-funded researchers reported that a surgically implanted stimulating device allowed four men to regain some leg movement after their voluntary muscles were completely paralyzed below the chest.
In a follow-up study, scientists at the University of California, Los Angeles, tested a nonsurgical method for stimulating the spinal cord. Called transcutaneous electrical nerve stimulation, the method delivers electrical current to the spinal cord via electrodes strategically placed on the skin over the spine.
However, it’s not enough to just develop something in the lab.
“Promising [projects] need publicity and commercialization” said Moynahan.
To that end, the institute has entered into a partnership to commercialize the implantable devices with Synapse Biomedical Inc.
“The partnership with Synapse Biomedical marks a pivotal step in our program because, not only will it serve as the manufacturer of the CWRU-developed Networked Neuroprosthesis and license the technology for its own use, but we anticipate the partnership being the first step in creating a sustainable business model for this technology to reach people with spinal cord injury,” said Moynahan in a press release.
For 13 years, Synapse Biomedical has been developing and commercializing a neurostimulation system to help patients with spinal cord injuries, amyotrophic lateral sclerosis, or other illnesses that affect breathing. The company sells its products in 25 countries.
In order to reach more patients with the new implantable technology Synapse is partnering with the University of Tokyo Institute of Industrial Science for development and clinical studies, as well as opening the Asian market.
Also involved is the Craig H. Neilsen Foundation, which is providing $1 million in seed money to the institute with the hope of making the neuroprosthetics available to patients who are unlikely to be served by traditional medical-device makers.
Since 2002, the foundation has awarded more than $75 million in grants to more than 1,000 nonprofit organizations throughout the United States and Canada.
According to a New York Times obituary in November 2006, the foundation founder was himself a man with a severe spinal cord injury.
“When a 1985 car accident left him paralyzed from the neck down, the University of Utah alumnus would not let this twist of fate hold him back. After returning to work at his family’s construction and real estate development business a year later, he went on to establish a thriving casino enterprise, Ameristar Casinos Inc., and eventually set up the Craig H. Neilsen Foundation, dedicated to helping people with an SCI [spinal cord injury] lead active, high quality lives and to promoting research to find a cure for paralysis,” the paper reported.
Besides money, the research group needed federal approval to begin clinical trials. They got that from the U.S. Food and Drug Administration.
This fall, the institute will begin clinical trials on 10 patients who will use the system for hand grasping and postural balance.
The business model the team has created is designed to be a lasting partnership. It sees its clientele as people with spinal cord injuries as well as patients who’ve suffered a stroke and other neurological disorders, according to Hunter Peckham, the Donnell Institute professor of biomedical engineering and distinguished university professor at Case Western Reserve.