Donna Coveney

Drug companies are fleeing the field of

stroke research. Over the past decade, hundreds of potential stroke medications have raised hopes and gobbled up funds, only to fail spectacularly in clinical trials. Stroke is on the rise, but scientists struggle to lure pharmaceutical giants back into the risky market for cerebrovascular drugs.

The solution, strangely enough, might be a robot.

Meet MIT-Manus, which, its creators hope, will bring drug investors back to the table. By interacting with stroke patients and logging their movements, MIT-Manus can detect whether an experimental drug is working long before full clinical trials put investors at risk of hefty financial losses. If drug companies are able to use robotics to nix doomed experiments early on, then investors may return to stroke drug development with renewed vigor, a new study in Stroke suggests.

"Most of the drug studies have failed, so the robot would help them to stop the study sooner, save the money, save the time and go on to the next thing," says Hermano Igo Krebs, a robotics researcher at MIT and lead author on the study.

Humble Beginnings

MIT-Manus began its career as a physical therapy robot. Patients manipulated its mechanical arm like a joystick and played simple games like Pong that helped them to relearn subtle motor skills after a stroke. "Patients love interacting with technology," says Krebs. "There is a perception, correct or incorrect, that technology means better care."

As the software became more sophisticated, researchers wondered whether MIT-Manus could serve not only as a physical therapist but also as a sort of clinical investigator. The robot was already programmed to collect motion data from the patient's arm movements. Krebs suspected that researchers could use that information to track patient improvement over time and determine whether experimental stroke drugs were having a tangible effect. "We wanted to use this technology for a dual purpose, not only to deliver therapy but also to evaluate the patient," Krebs says.

So Krebs and his team designed a computer program that translates the patient data stored in MIT-Manus into a numeric score that clinical investigators can chart in their analyses. While stroke researchers have historically relied on a similar scoring system, with human physical therapists doing the scoring, the robotic results require far fewer patients to determine whether an experimental stroke drug is effective.

"Pharmaceutical companies have calculated that they need about 800 patients to evaluate whether a drug is working or not," Krebs says. "But with only 240 patients, we could tell the company whether a drug is better than the control group."

Man vs. Machine

Still, some researchers in the field are hesitant to let robotic assessments supplant the opinions of seasoned clinicians. Stroke is a complex disease, and when human therapists assess stroke patients, they run specific tests but also note general signs of improvement that a robot could easily miss, says Daofen Chen, a program director of research at the National Institute of Neurological Disorders and Stroke. "It's not something you can capture, bio-mark and turn into a generic computer strategy," he says.

Given the complexity of the brain and how little scientists understand about the nature of stroke, Chen worries that it is too early in the game to funnel the broad rules of recovery into strict robotic protocols. "Patients are not robots," Chen says. "Robotic intervention has shown some degree of effectiveness, but the challenge is still how to use robots in a more useful way in clinics."

Krebs is not surprised that some scientists balk at using robots in a field in which human judgment has long reigned supreme. "Whenever you buck an established procedure, there is always a push-back," Krebs says. "But the economical advantage is so large that [drug companies] will prevail quite easily in saying that things need to be done this way."

Future Prospects

Krebs predicts that the FDA will continue to require companies to submit studies with at least 800 patients before approving new stroke drugs. But he suspects that once robotic results indicate that a certain drug shows promise, researchers will readily recruit extra patients to meet FDA standards. "If we show that the drug is working, the pharmaceutical companies will be very happy to collect the remaining 560 patients," he says.

Krebs is confident that the market for stroke medication will eventually bounce back. Meanwhile there are precious few stroke drugs currently in development. As stroke research lags behind other diseases such as cerebral palsy and Parkinson's disease, Krebs is already considering how best to bring MIT-Manus into other clinical trials.

"I cannot sit and wait for [the drug companies], because I don't know how long it will take for them to test something new," he says. "I'm now looking into how to extend this beyond stroke and into other kinds of neurological conditions."

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