Background Epidural prefrontal cortical stimulation (EpCS) represents a novel therapeutic approach with many unique benefits that can be used for treatment-resistant depression (TRD). Objective To examine the long-term safety and efficacy of EpCS of the frontopolar cortex (FPC) and dorsolateral prefrontal cortex (DLPFC) for treatment of TRD. Methods Adults (N = 5) who were 21–80 years old with severe TRD [failure to respond to adequate courses of at least 4 antidepressant medications, psychotherapy and ≥20 on the Hamilton Rating Scale for Depression (HRSD24)] were recruited. Participants were implanted with bilateral EpCS over the FPC and DLPFC and received constant, chronic stimulation throughout the five years with Medtronic IPGs. They were followed for 5 years (2/1/2008–10/14/2013). Efficacy of EpCS was assessed with the HRSD24 in an open-label design as the primary outcome measure at five years. Results All 5 patients continued to tolerate the therapy. The mean improvements from pre-implant baseline on the HRSD24 were [7 months] 54.9% (±37.7), [1 year] 41.2% (±36.6), [2 years] 53.8% (±21.7), and [5 years] 45% (±47). Three of 5 (60%) subjects continued to be in remission at 5 years. There were 5 serious adverse events: 1 electrode ‘paddle’ infection and 4 device malfunctions, all resulting in suicidal ideation and/or hospitalization. Conclusion These results suggest that chronic bilateral EpCS over the FPC and DLPFC is a promising and potentially durable new technology for treating TRD, both acutely and over 5 years.
Bibliographical noteFunding Information:
Medtronic, Inc. (Minneapolis, MN) donated the devices but was otherwise not involved in the study, particularly data acquisition, analysis, or drafting the article. Ziad Nahas, MD, declares no conflict of interest in relation to the work described and was funded by a National Alliance of Research for Depression and Schizophrenia ( NARSAD ) Independent Investigator Award. Brandon Bentzley, MD, PhD, declares no conflict of interest in relation to the work described and was supported by NIH grants F30 DA035065 and T32 GM008716 . Nolan Williams, MD, and Thomas Hopkins, BA, declare no conflict of interest in relation to the work described and were supported by NIH grant R25 DA020537 . No other contributors declare a conflict of interest in relation to the work described.
© 2016 Elsevier Inc.
- Brain stimulation
- Deep brain stimulation
- Epidural cortical stimulation
- Interventional psychiatry
- Treatment-resistant depression