Serious Adverse Events with DBS for Obsessive Compulsive Disorder

Dr Shock
November 17, 2008

deep brain stimulation

In Deep Brain Stimulation for treatment resistant depression with stimulation of Broadman area 25 (Cg 25) no consistent declines in memory for either verbal or visual material were noted after onset or maintenance of DBS over baseline. This makes DBS a procedure with out apparent cognitive side effects in treatment resistant depression. In a recent publication with DBS in the Subthalamic Nucleus for treatment resistant Obsessive Compulsive Disorder (OCD) no cognitive decline was found. The ratings of neuropsychological measures were not modified by stimulation.

nucleus subthalamicus dbs

In 17 patients participating in this 10-month, crossover, double-blind, multicenter study assessing the efficacy and safety of stimulation of the subthalamic nucleus one patient had a parenchymal brain hemorrhage (bleeding) resulting in a permanent finger palsy. Two patients had an infection leading to removal of the pulse generator. Seven transient motor and psychiatric symptoms induced by active stimulation occurred in the first month of stimulation and resolved spontaneously or rapidly after adjustment of the setting. Ten other patients also had serious but transient side-effects.Three patients became hypomanic, three suffered from anxiety, two of depressive symptomps the others suffered from transient neurological side-effects such as dyskinesia, trouble walking, dysarthria, dysphagia and facial asymmetry.

Deep Brain Stimulation of the subthalamic nucleus significantly reduced the symptoms of severe forms of OCD.

In conclusion, findings from this 3-month crossover study suggest that stimulation of the subthalamic nucleus may lessen the severity of obsessive–compulsive symptoms and improve global functioning in patients with refractory, severe OCD. Serious adverse events occurred in 11 of the 17 patients in whom stimulators were implanted. The occurrence of severe adverse events, the small number of patients, and the short duration of the study highlight the risks of stimulation of the subthalamic nucleus and the need for larger studies with longer follow-up. In addition to assessment in a larger number of patients, a comparison with other stimulation targets and surgical procedures would be desirable, as would an evaluation of the long-term benefits of stimulation of the subthalamic nucleus in patients with OCD, notably with respect to their quality of life and their ability to function in social and work environments.

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2 Responses to “Serious Adverse Events with DBS for Obsessive Compulsive Disorder”

  1. Hi Doc,

    I noticed that you’re still talking about and referring to “treatment resistant depression” when in fact CMS (Centers for Medicare and Medicaid Services), across the pond here in the U.S., denied insurance reimbursement for VNS Therapy as there is no such medical term as “treatment resistant depression” as indicated in their decision of May 4, 2007.

    “Vagus nerve stimulation is not covered for treatment resistant depression…”

    “These various indications that have been proposed for VNS illustrate that the term”treatment resistant depression” lacks a standard definition that has been scientifically validated, and appears to be subject to various interpretations. The National Clinical Practice Guideline for Depression in Primary and Secondary Care (2004) states an important point: “The term ‘refractory depression’, used to describe depression that has failed to respond to two or more antidepressants at an adequate dose for an adequate duration given sequentially, is not especially helpful. It does not take into account depressive subtypes, makes no distinction between treatment resistance, chronicity, relapse or recurrence, and fails to take into account what psychosocial factors may be preventing recovery or indeed whether the patient has had an adequate course of an appropriate psychotherapeutic treatment (Andrews & Jenkins, 1999)”.

    http://www.vnsdepression.com/pp10-010173-articles_5-4-07-CMS-Kills-Any-Hope-For-VNS.htm

    They recognize MDD (Major Depressive Disorder) and long-term treatment of chronic or recurrent depression but not TRD. It is also interesting to note that rTMS, recently FDA approved here in the U.S., and the ongoing DBS studies for depression do not refer to TRD. I guess they’re wise enough to have learned from the VNS fiasco.

    Warmly,
    Herb
    VNSdepression.com

  2. herb on November 21st, 2008 at 8:18 am
  3. rTMS is a approved in The Netherlands as well.Diplomatic solution for a serious problem, thanks for the information, didn’t know that, kind regards Dr Shock

  4. Dr Shock on November 21st, 2008 at 9:22 am

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