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.
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12 Comments to
“Is Deep Brain Stimulation (DBS) the Next Revolution in Depression Treatment?”
im simply cant imagine that enough people will opt for surgery, arguably the most intensive treatment for depression when other lower-risk high-reward options are on the table like therapy and medication. for the MOST depressed folks who have tried everything else, i can see this being a reasonable option, but no way it ever supplants either of the aforemention in popularity.
I largely agree, except that similar to laser eye surgery, it could become so widely done that it almost becomes commonplace. I suspect that won’t be the case, but you never know. Who would’ve thought that operating on a person’s eye would become so common (when the downside to a shoddy or messed-up surgery is significant — even possible blindness!).
Deep Brain Stimulation is meant for those with chronic, treatment resistant
depresson. It is a potential godsend for those who do not respond to medications,
medications and therapy, therapy alone and/or ECT which is supposed to be the most effective
treatment for major refractory chronic depression. It gives an option for the
millions of Americans who do not have treatment options or are running out.
Actually one of the patients that was tagged with a response was close. That patient was 2%(in the Hamilton rating system) off of being a nonresponder. So, I would say it is 50% effective. That doesnt bode well to me. The fascinating thing about DBS is the acute response to it. These leads me to believe, like in anything else, tolerance plays a important part in DBS.
I’m hoping this ariticle is referring to the show I viewed last week about two women who had received surgical implants in the brain in hopes to reverse their deep depression. Their psychiatrics had to make a connection to a device under their skin below their shoulder on their chest monthly.
I’m responding to this because I know someone who would make an ideal candidate for this kind of research. He has been severely disabled for the past 8 years because of depression and hospilized three times prior to 1999. He has received ongoing medication, a numerous amount of ECT treatments both as an in and out patient, and therapy, none of which has had any affect on his mental health. We have hoped and prayed for such a long time that something else could be tried to help this man. He is the father of my children and they have suffered dramatically because of his disease. They have basically lost their relationship and love from their father for most of their lives. My son, who is now 21 and away at school happened to view the program as well. He called me the other day and asked how his dad could have the opportunity for this miracle. Maybe, this would bring back the father to them they once knew. If there is any way or chance he can be involved as part of this research, please contact me at the above email address. Thank you
Yes Linda this is the same study that was shown on CBS. There is a pilot study going on but I’m not sure when it starts or ends. Here is a link where the study is being performed. http://www.brown.edu/Divisions/Medical_School/andera/profile.php?id=1100924993
There’s a phone number listed, but the study is at Brown University in Ohio.
Good luck
I would like to be in the study for Persistant Depression. Please send any information about being considered for the study. Thank you
I am interested in participating in a clinical trial for DBS for depression. I believe I meet the requirements for eligibility including having had ECT. Please send any information regarding consideration for the study.Sincerely , Paige
I have a client with severe depression I can count the good days she has out of one year. She is desperate to try surgery and has the means to afford this expense. She has been diagnosed with bipolar disorder, but for the last 13 years has been depressed with no mania. She has had several treatment of ECT which last for a couple of days, then her mood drops.
Please contact me with information on where this surgery is available any where in the world.
Michelle Pepper
I have suffered from depression for most of my adult life. I am very resistant to medications and live my life, at best, constantly sad; at worst, suicidal. Can you please tell me how I could get into a clinical trial for deep brain stimulation?
Liddy
Hi, here is where a clinical trial is going on at. It is in Atlanta, Georgia. http://clinicaltrials.gov/show/NCT00367003
The trial is free because the government pays for it. However, it will be very difficult to qualify for the procedure. If anyone goes through it please email at jackjuno@hotmail.com.
GOod luck
I am very interested in participting in a DBS trial for intractable depression and OCD. Does anyone know how to get into those trials?
Thanks!
Leslie
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Last reviewed: By John M. Grohol, Psy.D. on 27 Apr 2006
