NeuroVoices: Eric Leuthardt, MD, on Expanding and Streamlining the IpsiHand System

Eric Leuthardt, MD

This is a 2-part interview. To view part 1, click here.

Neurolutions, a medical device company, announced in April that the FDA had granted de novo market authorization and breakthrough device designation for its IpsiHand Upper Extremity Rehabilitation System, making it the first FDA-approved, device-leveraging brain-computer interface technology to assist patients with chronic stroke in rehabilitation.

Designed for in-home or clinic use, the IpsiHand system includes a robotic exoskeleton that is worn over the patient’s hand and wrist, an electroencephalogram (EEG)-based headset, and a tablet. The exoskeleton is lightweight, adjustable, and battery-powered, and designed to physically open and close the patient’s hand in response to signals from their brain.Developed by a team of innovators in Silicon Valley and neuroscientists from Washington University in St. Louis, the neuro-prosthetic and robotic capabilities of the IpsiHand System have been shown in clinical trials to provide both statistically and clinically significant outcomes for patients with chronic stroke.

The second half of NeurologyLive’sconversation with Eric Leuthardt, MD, founder and chief scientific officer of Neurolutions, headlines this week’s NeuroVoices segment. In this interview, Leuthardt provided background on the additional opportunities for the IpsiHand System, including how it can impact key cognitive and functional deficits, as well as how it can be acclimated into regular clinical care.

NeurolgyLive: How else would you like to study the IpsiHand System? Is there a potential to treat other patient populations?

Eric Leuthardt, MD: This is a platform technology that has the ability to expand to a number of stroke applications and indications. To be clear, we’re not there yet with the FDA. We will have to get more data and evidence. Projecting forward, we’re using this fundamental thinking of taking brain signals and coupling them with meaningful input to remodel neural circuits to improve the patient’s function. In the near-term, we’ve got additional opportunities.

We’ve focused on the hand and expanding to the lower extremity. We can think about other key cognitive and functional deficits that are common in stroke. Whether that be cognitive deficits such as neglect, for instance. These key items are what I would call “network-opathies.” You’ve distorted a circuit because of a stroke—can we remodel these to improve the patients? As far as timing, we will have to get more data. I’d like to think that a person can envision this idea throughout the spectrum of stroke recovery, especially for people who are severely affected and cannot participate in standard physical therapy.

The severely affected population that cannot do the normal movement-related physical rehabilitation regimes flattens them out for the ability to interact. If we’re able to tap into their brain and start to use that, then I think we have some real opportunities. That said, we’ve got to prove it, and we will have to get the data for that. But those are the opportunities that get me excited about the future.

How will this tool be streamlined for use in common clinical care?

When we think about the integration and initiation of advanced technology into care, it’s a complex ecosystem that ranges from reimbursement guidelines to physical and patient education, to various operational constraints. Each of these we need to address in a multi-pronged approach. That way we can create an integrated regulatory, educational, cultural, and patient-centric advocacy so that it becomes part of the fabric of how we perceive patients and their care. At the core, this has to be patient centric. If it focuses on the patients, it allows us to have meaningful conversations with stakeholders and every element of that complex ecosystem.

With MCIT [Medicare Coverage for Innovative Technology], because the IpsiHand system was identified as a breakthrough designation technology and FDA approved, this new legal structure can help expedite devices such as this one to get standard regulatory reimbursement. Hopefully, that can facilitate people getting access to the device through things such as Medicare and Medicaid.

Transcript edited for clarity. For more NeuroVoices conversations, click here.