According to researchers from the Cleveland Clinic and Brown University’s Butler Hospital, deep brain stimulation (DBS) may be the next potentially effective and revolutionary treatment for people with depression.

The study, Deep Brain Stimulation for the Treatment of Intractable Major Depression: Preliminary Results from a Multi-Center Prospective Trial, was conducted in six patients, four females and two males, with an average age of 48, who were enrolled in the study from 2003 to 2005. All six patients had a history of being highly resistant to other treatments, including medication, psychotherapy, and electroconvulsive therapy (ECT). Bilateral DBS leads were implanted in a region of the brain known as the ventral anterior internal capsule. Participants underwent standardized and detailed psychiatric, quality-of-life, and neuropsychological assessments on a regularly scheduled basis, both pre- and postsurgically.

At six months post-surgery, four of the six patients showed a clinically significant reduction in depression severity of 50 percent or greater on the Montgomery-Asberg Depression Rating Scale. Quality-of-life measures improved as well, and patients showed progressive improvements in mood and functioning over time. One patient experienced persistent occipital pain that was alleviated with repositioning of a subcutaneous connector wire.

Deep brain stimulation, or DBS, has been used to treat intractable pain for several decades, and more recently, use of this technology has expanded to the FDA-approved indications for Parkinson’s disease and other movement disorders. DBS is also under investigation in the treatment of epilepsy and other debilitating neurological conditions. DBS surgery involves the placement of tiny implantable electrodes into specific parts of the brain that are functioning abnormally. These electrodes emit tiny pulses of electrical stimulation to block the abnormal activity in the brain, which causes a variety of symptoms – such as pain, tremors, movement problems; as well as obsessions, moods and anxieties associated with psychiatric disorders. The success of DBS is dependent on the surgical team’s ability to precisely pinpoint the specific brain area for stimulation. The advantage of DBS is that it is reversible, nondestructive, and can be modified by adjustment of the stimulator settings after implantation.

“Since 2001, this team of investigators has been using DBS for treatment of obsessive compulsive disorder (OCD). Because DBS for OCD showed significant benefits in improving patient’s anxiety and obsessions, as well as improvements in co-morbid depression, the research team initiated a new study analyzing the effects of DBS on patients with major depression,” stated Dr. Rezai, one of the study’s researchers.

Results Encourage DBS Maker to Pursue Larger Clinical Trials

Based in part on promising study results presented this week at an international neurosurgical meeting, Medtronic, Inc., today announced its intentions to pursue a major clinical trial of the company’s deep brain stimulation (DBS) technology in the treatment of severe and intractable depression, a disabling form of the psychiatric disorder affecting millions of people worldwide. Medtronic is a maker of DBS equipment and technologies.

More than 30,000 people worldwide have received DBS therapy with a Medtronic Kinetra(R) or Soletra(R) neurostimulation system. More than 50 of these people have taken part in several separate “pilot” studies of DBS therapy as a potential treatment for severely disabling psychiatric disorders, including depression and OCD.

“We are in the process of finalizing our plans for a major clinical trial of DBS therapy as a treatment for chronically severe depression that has not responded to conventional treatments,” said Dr. Richard E. Kuntz, M.D., senior vice president of Medtronic and former chief scientific officer of the Harvard Clinical Research Institute (HCRI), which he founded. “In collaboration with teams of leading neurosurgeons and psychiatrists, we will be working with the FDA in the coming months to complete a study design that meets the rigors of the agency’s review process and our own high standards for evidence of efficacy.”

What it Means to People Who Have Depression

Very little can be conclusively said about such a small-scale study of only 6 people, where 2 of them did not receive benefits from the treatment. Put into context, if one more person hadn’t received any benefit from the DBS treatment, the treatment would have no better than 50/50 chance in helping someone with depression. Furthermore, the study cites the use of the Montgomery and Asberg Depression Rating Scale as proof of “clinically significant” reduction in depression. The Montgomery and Asberg scale is a clinican-based rating scale, not a patient-based scale. The same clinicians who are administering the treatments and have reason to be biased toward the benefits of the treatment are apparently the ones rating patients on how depressed they are.

Larger-scale clinical trials will demonstrate the effectiveness (or lack thereof) of the DBS treatment for depression. Of course, the risks of neurosurgery shouldn’t be underestimated either. DBS treatment for depression, if it ever becomes approved, will be for serious, chronic depression, like rTMS or ECT. It will not replace antidepressants or psychotherapy as the main treatment options for people who are diagnosed with depression.

Dr. John Grohol is the CEO and founder of Psych Central. He is an author, researcher and expert in mental health online, and has been writing about online behavior, mental health and psychology issues -- as well as the intersection of technology and human behavior -- since 1992. Dr. Grohol sits on the editorial board of the journal Cyberpsychology, Behavior and Social Networking and is a founding board member and treasurer of the Society for Participatory Medicine.

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    Last reviewed: By John M. Grohol, Psy.D. on 27 Apr 2006
    Published on PsychCentral.com. All rights reserved.