Brain Cool, a subsidiary of Swedish medical device company Dignitana, has announced a Phase I clinical trial of its medical brain cooling system, for the treatment of stroke patients.
The trial, conducted at University of Edinburgh, will be tested on healthy volunteers to measure efficacy of brain cooling rates.
Using a patented cooling method developed by Dignitana, the Brain Cool system allows cooling of the neck, which helps to speed perfusion and cooling of blood before it reaches the brain, a critical intervention for patients with stroke.
A reduction of body temperature to 35 °C induces a kind of hibernation status of the brain that may help protect the brain from stroke-induced damage, according to Brain Cool.
Previous pilot studies also suggest that even a small reduction of the brain temperature, as little as 1°C, can be beneficial in treating stroke patients, reducing mortality rates as well as improving quality of life for stroke survivors.
Brain Cool board chairman and Dignitana CEO Martin Waleij said nearly 150,000 people suffer from a stroke each year in the UK, meaning measures like brain cooling to offer protection of the brain are a strong patient need.
"We expect the findings of this clinical trial at the University of Edinburgh to firmly confirm our pilot evaluations and provide solid clinical evidence for the use of medical cooling primarily in stroke patients," Waleij said.
"In addition to the indication for use in stroke, new patent applications have also been submitted in the US complementary to the existing worldwide patents of Dignitana AB.
"We are opening the door to a new world of advanced healing that could improve quality of life for people with stroke, traumatic brain injury, cardiac arrest, and neonatal asphyxia."
The company said it is currently developing a portable, advanced Brain Cool model for stroke patients for whom immediate intervention can be critical.