Israeli startup BrainQ said that a pilot trial of 25 stroke patients treated with its artificial intelligence (AI)-based electromagnetic therapy has shown “striking” results in reducing disability following a stroke.
The Jerusalem-based startup has developed a wearable hat-like device that looks like a large round hair-dryer. This cloud-connected device aims to treat damaged areas of the brain with electromagnetic waves, or “artificial brainwaves,” that mimic healthy neural networks, to rebalance the brain and restore it to its normal function.
The results of the double-blind randomized controlled pilot trial will be presented at the International Stroke Conference on March 17-19. The data shows that patients recovered 77% faster from the disabilities caused by the stroke and were able to resume normal life.
Based on these results, the company got FDA Breakthrough Device Designation for its therapy earlier this year, which will enable the startup to work closely with US regulators to speed up the development and the final approval of the device. The technology could ultimately have broader application for neurological disorders like spinal cord injury, Parkinson’s and MS, the company said.
A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. Brain cells begin to die in minutes. Treatment requires immediate action, which can reduce brain damage and other complications. Every year more than 795,000 in the US have a stroke, and stroke-related costs in the US totaled almost $46 billion between 2014 and 2015, according to the Centers for Disease Control and Prevention. The condition is one of the biggest causes of disability.
“Some 15 million people are treated for stroke every year and stroke is the main reason for disability, with 75% of patients suffering from long term disability,” said Yotam Drechsler, the co-founder and CEO in a phone interview. The data shows that 77% of the patients treated with BrainQ’s device “recovered to having little to no disability, which is a very striking result.”
“This means that our device manages to reverse the disability,” he said.
Standard care means that there is very narrow window of opportunity to reverse disability and prevent damage from a stroke, he said. “This window is applicable for less than 5% of patients.”
After a stroke, patients can have different levels of disabilities, as measured by the modified Rankin Scale (mRS). A score of 0 to 1 means no symptoms and no significant disability. A score of 2 indicates slight disability, with the patient able to look after their own affairs without assistance but unable to carry out all previous activities. A score of 3 means there is a moderate disability, when the patient needs some help but is able to walk unassisted; 4 indicates moderate to severe disability, with patients unable to attend own bodily needs and unable to walk unassisted; 5 indicates severe disability, with patients requiring constant nursing care and attention, bedridden and incontinent. Six indicates patients who have died from the stroke.
BrainQ’s trial was performed on patients with level 3-4 disability on the modified Rankin Scale, and showed that after eight weeks of treatment, they had scores of 1 or zero on the mRS, meaning they had either no symptoms or minor symptoms. Only 25% of the subjects in the control group scored 1 or less, according to the data, and 92% of the subjects in the treatment group improved by two or more mRS points.
The BrainQ subjects’ mRS scores improved by an average of 2.5 points over the course of the study, compared with 1.3 points in the control group. No related adverse events were recorded, the company said. Traditional treatments lead to an average of recovery of 1.1 points, the company said.
To mimic the natural state of the brain, BrainQ mapped out the neural networks to study their electromagnetic activity; translated this activity into machine learning algorithms and created models which it then “fertilizes” the brain with, through the electromagnetic therapy, helping it revert to close to its original state.
“These pilot results are striking, as BrainQ’s therapy suggests a beneficial effect in the subacute phase,” said Dr. Jeffrey Saver, director of the UCLA Comprehensive Stroke and Vascular Neurology Program, and a lead principal investigator for BrainQ’s next phase of clinical trials. “The current leading interventions for stroke are effective only in the few hours post-stroke and applicable to less than 5-10% of patients. This technology may have the ability to extend the time period in which corrective therapy can be delivered from hours to days and even weeks, and be applicable to a much larger patient population.
“With 800,000 strokes each year in the US alone, this therapy has the potential to greatly advance stroke care.”
The firm is gearing up for an upcoming larger, multi-center trial in the US that will have hundreds of patients, said Drechsler, the CEO. The breakthrough designation by the FDA means an expedited development track for the product and that it will be eligible for MediCare refunds as soon as final FDA approval is granted for sale of the product — hopefully in three to four years, he said.
“There is a massive population with an unmet need,” Drechsler said, adding that the technology “brings hope to once independent people who suddenly after a stroke find they can no longer live alone.”
The results of the trial will be presented in an abstract titled “Artificial Intelligence-powered Non-invasive and Frequency-tuned Electromagnetic Field Therapy Improves Upper Extremity Motor Function in Sub-acute Stroke Patients: A Pilot Randomized Controlled Trial.” The data from the study has not been peer-reviewed yet.