Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database
- Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin,
- Department of Neurology, Orlando Regional Medical Center,
- Department of Neurology, University of Central Florida College of Medicine, Orlando, Florida, United States.
Mokshal H. Porwal, Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin, United States.
DOI:10.25259/SNI_613_2022Copyright: © 2022 Surgical Neurology International This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, transform, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.
How to cite this article: Mokshal H. Porwal1, Hamsitha Karra1, Umesh Sharma2, Danish Bhatti3. Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database. 02-Sep-2022;13:399
How to cite this URL: Mokshal H. Porwal1, Hamsitha Karra1, Umesh Sharma2, Danish Bhatti3. Deep brain stimulation for refractory obsessive-compulsive disorder: A review and analysis of the FDA MAUDE database. 02-Sep-2022;13:399. Available from: https://surgicalneurologyint.com/surgicalint-articles/11843/
Background: Deep brain stimulation (DBS) is used as a treatment option for patients diagnosed with a form of obsessive-compulsive disorder (OCD) that is highly resistant to conventional treatment methods. In 2009, DBS was granted a humanitarian device exemption-approval by the Food and Drug Administration after promising preliminary data. Monitoring of long-term safety data through post market surveillance of adverse events has not yet been conducted for DBS in OCD patients. This study aims to address this critical knowledge gap.
Methods: All patient- and device-related (PR; DR) reports from January 1, 2012, to December 31, 2021, were downloaded and compiled from the manufacturer and user facility device experience (MAUDE) database pertaining to DBS for OCD using the product class name “Deep Brain Stimulator For OCD.” Data in this study were examined using descriptive statistics to evaluate for frequency of reporting.
Results: The most frequently reported PR adverse event categories included psychiatric (40%), neurological (19%), other (14%), decreased therapeutic response (10%), and infections (10%). The most frequent DR reports were high impedance (14%), energy output problem (7%), battery problem (7%), malposition of device (7%), and improper/incorrect procedure or method (7%).
Conclusion: The PR and DR adverse events in our study align with the previous findings of adverse events. They also further solidify that DBS for refractory OCD may be a viable option for the right patient population. However, further studies are essential given the limitations of the MAUDE database.
Keywords: Deep brain stimulation, Food and drug administration manufacturer and user facility device experience database, Neuropsychiatry, Obsessive-compulsive disorder
While most patients diagnosed with obsessive-compulsive disorder (OCD) find therapeutic relief of their symptoms with medication, therapy, or a combination of both, some patients have a form of the disease that is highly resistant to conventional treatment methods called refractory OCD. For this unique subset of patients, an uncommon treatment option is deep brain stimulation (DBS). In 2009, DBS was granted a humanitarian device exemption (HDE)-approval by the Food and Drug Administration (FDA) after promising preliminary data.[
This study analyzed post market surveillance data within the FDA MAUDE database. This is a publicly available database maintained by the FDA for tracking adverse events associated with medical devices. Reporting to the database is required by manufacturers, importers, and device user facilities. Reporting is voluntary by health-care professionals, patients, and consumers. Since this database is publicly accessible and consists of de-identified data, no ethics approval was required.
Data mining and classification
All patient- and device-related (PR;DR) reports from January 1, 2012, to December 31, 2021, were downloaded and compiled from the MAUDE database pertaining to DBS for OCD using the product class name “Deep Brain Stimulator For OCD,” revealing a total of 60 reports. Of these, reports were separated into PR and DR reported and those without sufficient information were excluded from the study. This process is represented in
Data in this study were examined using descriptive statistics to evaluate for frequency of reporting. The FDA suggests MAUDE data cannot be used for inferential statistics or to derive trends due to the nature of spontaneous reporting.
During the study period, a total of 60 medical device reports were extracted. After removing 16 reports with insufficient information and no adverse events or device problems, 44 PR and 37 DR events were recorded. Twenty-two reports had both PR;DR adverse events.
DBS and OCD
DBS involves placing electrical leads on specific regions on the brain and delivering a high-frequency current to disrupt and reduce the output from that region without resulting in permanent tissue destruction.[
In this study, we demonstrated that patients implanted with DBS for the treatment of OCD experienced a myriad of adverse events associated with both device implantation and stimulation. This finding was not abnormal or unexpected. According to current literature, there are several risks associated with DBS usage in general, many being mild and reversible.[
Overall, our results align with the previous findings of adverse events associated with DBS in OCD patients. In our review, the most common category of adverse events reported by patients was psychiatric in nature, with 15% of patients experiencing cognitive changes, 7% experiencing anxiety, and 6% reporting depression and emotional changes. Decreased therapeutic response and infections were also seen in almost 10% of patients. Neurological adverse events, such as electric shock, sleep disturbances, and intracranial hemorrhage, were seen in a small percentage of patients. Uniquely, our study also looked at adverse device reports and found that high impedance was the most common complaint, followed by energy output, and battery problems. This supports that fatal malfunction of these devices are uncommonly reported. The PR and DR adverse events in our study further solidify that DBS for refractory OCD may be a viable option for the right patient population. However, further studies are essential given the limitations of the MAUDE database.
OCD epidemiology and pathophysiology
The national institute of mental health defines OCD as an illness, where a person experiences uncontrollable, reoccurring thoughts, known as obsessions, and/or the urge to repeat behaviors, known as compulsions. OCD is a chronic condition with an estimated lifetime prevalence of 2.3%, impacting a higher proportion of individuals than schizophrena.[
While the exact cause of OCD is still unknown, it is widely accepted that a complex interplay of neurobiology, genetics, and environmental factors play a role. In terms of pathophysiology, several studies involving positron emission tomography, single-photon emission computed tomography, and functional magnetic resonance imaging have displayed abnormal levels of activity in the orbitofrontal cortex, the anterior cingulate cortex, and the dorsolateral prefrontal cortex in patients diagnosed with OCD.[
Risk factors for OCD
Genetics are thought to contribute to the emergence of OCD. It has been reported that the morbid risk of OCD was significantly greater in the first-degree relatives of OCD patients than those of healthy subjects.[
Environmental factors, particularly trauma during childhood and adolescence, have also been linked with the development of OCD. One study found that monozygotic twins who scored highly on a questionnaire asking about obsessive-compulsive symptoms reported more experiences of sexual assault than monozygotic twins who scored low on the questionnaire; all victims of sexual assault were women, which could be a possible explanation for the higher incidence rate of OCD in women as compared to men.[
Treatment options for nonrefractory OCD
Current treatment options for OCD attempt to address these complex elements contributing to the disease’s etiology and presentation. One of the predominant treatments for OCD is cognitive behavioral therapy (CBT), specifically a form known as exposure and response prevention (ERP) therapy.[
In addition to behavioral therapy, pharmacotherapy of OCD has also been proven to be effective in controlling the debilitating symptoms of the disease. In the 1960s, drug therapy for the treatment of OCD symptoms began with the efficacious results of clomipramine, a tricyclic antidepressant (TCA) that most specifically inhibits serotonin reuptake.[
Refractory OCD and surgical intervention
While CBT and/or pharmacotherapy significantly improve the quality of life in OCD patients and should be considered first-line treatments, few patients diagnosed with OCD experience complete remission of symptoms.[
Neurosurgery was used extensively in the 1940s and 1950s for the treatment of psychiatric disorders before being almost completely abandoned due to public criticism, ethical concerns, and the emergence of effective pharmacotherapy in the mid-1950s.[
The limitations in this study relate to the inherent limitations of the MAUDE database. Data are reported spontaneously; therefore, no conclusions can be made about incidence or causality since there is no information on the total number of devices or patients. MAUDE data merely reflect reporting frequency which may allow for detection of the possibility of an adverse event occurring, without revealing risk. Per the FDA, MAUDE data are not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. In addition, there is minimal awareness of the database by health-care providers, leading to likely underreporting of adverse events. Although there are inherent limitations to the MAUDE database, our results highlight some important PR and DR complications that can help optimize patient counseling, management, and drive essential future research.
Our study of the post market surveillance data of DBS devices for refractory OCD using the MAUDE database aligns with previous findings of adverse events. In our review, the most common category of adverse events reported by patients was psychiatric in nature, with 15% of patients experiencing cognitive changes, 7% experiencing anxiety, and 6% reporting depression and emotional changes. Decreased therapeutic response and infections were also seen in almost 10% of patients. Neurological adverse events, such as electric shock, sleep disturbances, and intracranial hemorrhage, were seen in a small percentage of patients. Uniquely, our study also looked at adverse device reports and found that high impedance was the most common complaint, followed by energy output, and battery problems. This supports that fatal malfunction of these devices are uncommonly reported. The PR and DR adverse events in our study further solidify that DBS for refractory OCD may be a viable option for the right patient population. However, further studies are essential given the limitations of the MAUDE database.
Patients’ consent not required as patients’ identities were not disclosed or compromised.
There are no conflicts of interest.
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