By Michelle Jaffee
For people impaired by severe, debilitating obsessive-compulsive disorder who remain unresponsive to conventional treatments, including medications and cognitive-behavioral therapy, deep brain stimulation is approved by the U.S. Food and Drug Administration under a humanitarian device exemption.
But the treatment — which has been used in more than 200,000 people worldwide, mostly for movement disorders such as Parkinson’s disease — faces a “crisis of access” when it comes to the neuropsychiatric condition of OCD, according to a comment article published today in Nature Medicine by an international panel of experts.
The 42-member, multi-nationality panel was co-led by University of Cologne neurosurgeon Veerle Visser-Vandewalle, M.D., and Michael Okun, M.D., executive director of the Norman Fixel Institute for Neurological Diseases at UF Health and chair of UF neurology.
The experts argued that, while effective in a majority of well-selected patients with severe cases, deep brain stimulation is underutilized for treatment-refractory OCD.
“Action is needed,” the authors wrote, “by psychologists, psychiatrists and insurers so that patients with otherwise intractable cases can receive this therapy to improve their mental health.”
OCD, which affects 2-3% of the worldwide population, is a condition in which people have recurring, unwanted thoughts and repetitive behaviors that, in the worst cases, may cause significant disability and impair quality of life. Conventional treatments include cognitive-behavioral therapy and medication, usually serotonin-reuptake inhibitors, according to the article.
In a small fraction of cases, the condition remains debilitating despite treatment, and in those cases, the patient should be considered as a candidate for deep brain stimulation, Okun said.
Yet many obstacles stand in the way, according to the article: insurance denials, historical bias, skepticism of evidence, lack of awareness and scarcity of psychiatrists trained in the technique.
The authors wrote that “patients with severe OCD are being denied access to this potentially life-saving therapy, in part because of denial of insurance coverage, which makes the therapy financially infeasible for almost all patients. A recent study in the United States showed that only 50% of identified candidates for DBS for OCD were given this treatment, whereas less than 40% of patients received coverage from their insurance company.”
Deep brain stimulation, known as DBS, involves the surgical placement of electrodes into a specific brain region; the electrodes then are connected to a pulse generator placed under the skin in the chest. In the months and years following surgery, settings of the device are adjusted to maintain optimal levels for treatment.
“These are advanced, personalized, circuit-based treatments that can really change people’s lives,” Okun said. “We need to better and more effectively educate psychiatrists, internists and family practitioners so that they are able to appropriately refer patients for this treatment.”
The therapy was approved by the FDA under a humanitarian device exemption in 2009 for selected cases of treatment-refractory OCD; the same year, a specific DBS system was granted a CE “Conformité Européenne” mark certifying that a product has met health, safety and environmental requirements of the European Union. DBS has been used since 1987 for movement disorders and has a proven safety record, the authors write.
In making their argument to broaden the use of DBS for OCD, the authors detail small clinical trials in countries such as the Netherlands, Belgium and France that have shown the treatment to be effective.
“We have multiple small but blinded and randomized-controlled clinical trials that provide collective evidence that we can implant deep brain stimulation systems in people who have this disorder and meaningfully change their quality of life and ability to function,” Okun said. “There is a serious hurdle for access.”
Okun and UF neurosurgeon Kelly Foote, M.D., performed their first NIH-funded case of DBS for OCD almost 20 years ago. Along with then-UF psychiatrist Wayne Goodman, M.D., they treated six clinical trial participants who had OCD, and those cases were among the original 26 presented to the FDA in seeking approval of DBS for OCD, Okun said.
“Of the six severely debilitated, treatment-refractory OCD patients we treated, four responded,” said Foote. “And that’s consistent with the results seen in larger studies — about two-thirds of these most severely affected people have responded to DBS therapy.”
“Internationally, we have evidence and we have approvals, but those don’t necessarily translate to access,” he said. “So, people are not getting the therapy, even though it could be profoundly life-changing.”