title: Five-Year Follow-Up of Bilateral Epidural Prefrontal Cortical Stimulation for Treatment-Resistant Depression.
abstract: Epidural prefrontal cortical stimulation (EpCS) represents a novel therapeutic approach with many unique benefits that can be used for treatment-resistant depression (TRD).
  
  
  
  To examine the long-term safety and efficacy of EpCS of the frontopolar cortex (FPC) and dorsolateral prefrontal cortex (DLPFC) for treatment of TRD.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Stanford University, Stanford, CA, USA. Electronic address: nolanw@stanford.edu.
authors.forename: Nolan R
authors.initials: NR
authors.lastname: Williams
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: E Baron
authors.initials: EB
authors.lastname: Short
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hopkins
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Stanford University, Stanford, CA, USA.
authors.forename: Brandon S
authors.initials: BS
authors.lastname: Bentzley
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Greg L
authors.initials: GL
authors.lastname: Sahlem
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Stanford University, Stanford, CA, USA.
authors.forename: Jaspreet
authors.initials: J
authors.lastname: Pannu
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Matt
authors.initials: M
authors.lastname: Schmidt
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Jeff J
authors.initials: JJ
authors.lastname: Borckardt
authors.affiliation: Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Jeffrey E
authors.initials: JE
authors.lastname: Korte
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA; Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, USA.
authors.forename: Mark S
authors.initials: MS
authors.lastname: George
authors.affiliation: Department of Neurosciences, Medical University of South Carolina, Charleston, SC, USA.
authors.forename: Istvan
authors.initials: I
authors.lastname: Takacs
authors.affiliation: American University of Beirut Medical Center, Beirut, Lebanon.
authors.forename: Ziad
authors.initials: Z
authors.lastname: Nahas
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061218:Depressive Disorder, Treatment-Resistant / Q000628:therapy*; D004388:Dura Mater; D004599:Electric Stimulation Therapy / Q000379:methods*; D004824:Epidural Space; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017397:Prefrontal Cortex; D016896:Treatment Outcome; D055815:Young Adult
keywords: Brain stimulation; Deep brain stimulation; Epidural cortical stimulation; Interventional psychiatry; Treatment-resistant depression