Dr. Wayne Goodman, chair of the Menninger Department of Psychiatry and Behavioral Sciences at Baylor College of Medicine, and his collaborators were awarded a grant by the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, under the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. This will support research toward developing a new generation of deep brain stimulation (DBS) technology intended to help patients with difficult-to-treat obsessive compulsive disorder.
This is the NIH’s third round of grants to support the goals of the initiative, bringing its total fiscal year 2016 investment to just over $150 million.
In 2013, President Obama launched the BRAIN Initiative with the goal of creating deeper understanding of devastating brain disorders while also developing new technology and treatment through innovative research. NIH is one of four federal agencies, including the National Science Foundation, the Food and Drug Administration and the Defense Advanced Research Projects Agency, involved with the initiative.
Goodman and his collaborators, Dr. David Borton with Brown University School of Engineering and Dr. Jeffrey Cohn with the University of Pittsburgh, were awarded $1.5 million per year for five years. Their industry partner, Medtronic, will furnish state-of-the-art medical devices for the research project.
DBS is a widely used procedure for the treatment of movement disorders such as Parkinson’s disease. Worldwide, more than 140,000 patients have received DBS. A neurosurgeon places electrodes in the brain and connects them to a pacemaker-like device that produces electrical stimulation. The Food and Drug Administration has granted limited approval, called a Humanitarian Device Exemption, for use of DBS in adults with treatment-resistant OCD who meet certain criteria. No other psychiatric disorder has a similar approval status for neurosurgery.
“Currently, most FDA-approved DBS devices can only be set to continuous stimulation by the physician who programs the device and finds the right settings to control symptoms and not produce side effects. This may take a matter of weeks or months to make the adjustments,” Goodman said. This proposal aims to develop a prototype “adaptive” DBS system that would adjust stimulation automatically in response to the patient’s changing clinical needs.
According to Goodman, one available DBS system approved for drug-resistant epilepsy does not use continuous stimulation. Instead, the system applies stimulation when necessary. Goodman explained that the device works by sensing abnormal brain activity that signals the onset of a seizure. Another brain electrode produces a stimulus to disrupt that aberrant activity and abort the seizure. Goodman and his colleagues would like to take this concept and apply it to OCD treatment with DBS.
“We proposed a pilot study in 10 subjects with severe, treatment-resistant OCD,” Goodman said. “In our first five subjects we’re going to be targeting the same area of the brain, called the ventral striatum, that is currently approved for treatment under the Human Devise Exemption from the FDA. The main difference will be that now the device being implanted can record brain activity, not just stimulate.”
Goodman explained that they first want to train a computer that is in the room with the patient and programmer to be able to recognize what behavioral state the patient is in. In particular, they will try to train the computer to recognize whether the patient’s OCD is worse or whether they’re hypomanic, which can be one of the behavioral side effects of stimulation. Hypomania is characterized by an exaggerated elevation in mood and energy.
It can be difficult to strike the right balance of stimulation because if it’s too high the patient will be hypomanic and if it’s too low it won’t work, Goodman said. Training of the computer would be done with the assistance of a camera-based computer system, developed by Cohn, which can automatically detect and classify different emotions based on facial expressions. This will allow the computer to recognize the patient’s emotions in real time and learn the patterns of brain activity associated with those different states.
After five years of research, the hope is to devise a smarter prototype DBS device fully contained in the body that can respond to the changing condition of the patient and deliver stimulation as needed, Goodman said.
“In addition to improving DBS treatment, we have a unique opportunity to learn a great deal about the brain circuitry that causes obsessive compulsive behavior or is associated with naturally occurring hypomania as happens in bipolar disorder. The long-term goal would be to use these data to develop less invasive treatments,” he said.
OCD is a common, persistent and often disabling neuropsychiatric disorder marked by unwanted and distressing thoughts (obsessions) and irresistible repetitive behaviors (compulsions). OCD affects 2 to 3 percent of the U.S. population and is responsible for substantial functional impairment. The only established first-line treatments for OCD are cognitive-behavioral therapy with exposure/response prevention and serotonin reuptake inhibitor medications. Approximately 30 to 40 percent of patients fail to respond to either of these treatment methods.