The first treatment breakthrough of its kind for survivors of traumatic brain injury (TBI) or stroke will be published in the December 1 issue of the journal CNS Drugs, with an accompanying editorial.
The ground-breaking study provides clinical evidence that, for the first time, chronic neurological dysfunction from stroke or traumatic brain injury can rapidly improve following a single dose of a drug that targets brain inflammation, even years after the initial event. There are 5 million people living in the U.S. after TBI and 4.5 million living in the U.S. after stroke, and this is the first treatment of its kind ever available for TBI or stroke survivors after hospital discharge.
The observational study of 629 patients, conducted over the course of nearly two years, documents a diverse range of positive effects, including statistically significant rapid clinical improvement in motor impairment, spasticity, cognition, etc. in the stroke group, with a similar pattern of improvement seen in the traumatic brain injury (TBI) group. The study involved 617 patients treated an average of 42 months after stroke and 12 patients treated an average of 115 months after TBI, long after further spontaneous meaningful recovery would be expected. The study was conducted at the Institute of Neurological Recovery utilizing a novel drug delivery method, invented by Edward Tobinick M.D., lead author of the study.
"These results represent a sea change in the therapeutic possibilities for stroke and TBI patients," said Steven Ralph PhD, Associate Professor at Griffith University School of Medical Science in Australia. Professor Ralph recently led a team of physicians to the INR for training in the new treatment method. "Our team observed, first hand, rapid clinical improvement in patients following this brief office treatment. Rarely do we see such a radical breakthrough in medical treatment as this. A previous example was the advance with thrombolytic therapy for acute stroke. However, no similar treatment has existed for this type of chronic brain dysfunction until now," said Professor Ralph.
The study's significance is underlined by average age of the TBI population, many of whom have been injured as teen-agers.