Eric Leuthardt, MD, one of the inventors of IpsiHand, shows how the device fits on the hand and wrist. Photo by Elizabeth Holland Durando

A first-of-its kind device, called IpsiHand, will soon be available to people working to recover hand and arm movement after a stroke. And it works by using a technology called BCI, short for brain-computer interface. In fact, it is the first stroke-rehabilitation device that relies on BCI. The device is not yet available to patients, but its developer, a Washington University startup called Neurolutions Inc., is preparing to bring the device to market.

The IpsiHand system includes a wearable robotic exoskeleton that fits over a person’s hand and wrist, where it assists with opening and closing the hand based on the person’s thoughts. By mentally controlling the IpsiHand exoskeleton through BCI technology, people with limited mobility caused by stroke may improve their upper-extremity motor function, giving them more purposeful and effective movement of the affected hand, wrist and arm. Designed for use in the home or clinic, the system may assist in recovering critical abilities such as eating, grasping objects and performing other everyday tasks.

“Generally, any motor impairments experienced by a patient six months after a stroke have been considered permanent,” says Washington University neurosurgeon Eric Leuthardt, MD, an inventor of the technology that makes IpsiHand work. Leuthardt, who treats patients at Barnes-Jewish Hospital, also is a professor of biomedical engineering, and of mechanical engineering and applied science, and section chief of the Division of Neurotechnology in the Department of Neurosurgery. “What we’ve found with this device is that many patients can get a meaningful improvement in recovery of upper-extremity movement when we wouldn’t expect them to get any. That’s not really true for any of the current therapies for stroke aimed at restoring function after the initial recovery period. One of the key elements that made it a breakthrough was the innovative use of a brain-computer interface. It’s also what gets us incredibly excited to be able to create a novel solution that may help millions of stroke patients.”

IpsiHand is intended for stroke survivors who have chronic difficulty in moving or controlling an arm and hand, and was designed for use in the home as well as in the clinic. In clinical trials, stroke patients who wore the device and engaged in the therapy for approximately five days a week for 12 weeks showed statistically significant improvement in motor control. Such an improvement could mean the difference between being able to put on a pair of pants independently or being unable to do so. The IpsiHand system has received “Breakthrough Device” designation as part of an FDA initiative that promotes the development of innovative and effective solutions to critical, unmet health needs. Once a device receives this designation, the FDA prioritizes the application to ensure timely review and market entry.

The underlying BCI technology was spearheaded by Leuthardt, who cofounded Neurolutions in 2007 with Daniel Moran, PhD, a professor of biomedical engineering at the university’s McKelvey School of Engineering. Biogenerator and Ascension Ventures were critical for the company’s development and technical advancement. The company is currently led by CEO Leo Petrossian, PhD, and chairman of the board Fred Khosravi.

“Neurolutions’ success can be attributed to its multidisciplinary team,” Moran says. “It began as a research collaboration between researchers in the departments of Neurosurgery and Biomedical Engineering and then added more WashU expertise when researchers in the Department of Neurology and the programs in Physical Therapy and Occupational Therapy joined the team. The ability to easily collaborate within the WashU clinical and scientific community is what makes startups like Neurolutions thrive. Later, it was the belief from Tara Butler and Ascension Health Ventures, design and development led by Kern Bhugra, and the new company leadership led by Leo Petrossian and Fred Khosravi that brought us across the finish line.”

“It is exciting to say that this is the first FDA-approved brain-computer interface for rehabilitation,” Leuthardt says. “People have been trying for a long time to convert BCI from an experimental technology into something that will truly help patients. With this, we’ve shown that BCI is finally ready for prime time. I sincerely hope there are many more such devices to follow.”

Originally published by Washington University School of Medicine at medicine.wustl.edu/news