PMID- 21709597
OWN - NLM
STAT- MEDLINE
DCOM- 20120810
LR  - 20220409
IS  - 1524-4040 (Electronic)
IS  - 0148-396X (Linking)
VI  - 69
IP  - 5
DP  - 2011 Nov
TI  - Epidural cortical stimulation of the left dorsolateral prefrontal cortex for 
      refractory major depressive disorder.
PG  - 1015-29; discussion 1029
LID - 10.1227/NEU.0b013e318229cfcd [doi]
AB  - BACKGROUND: A significant number of patients with major depressive disorder are 
      unresponsive to conventional therapies. For these patients, neuromodulation 
      approaches are being investigated. OBJECTIVE: To determine whether epidural 
      cortical stimulation at the left dorsolateral prefrontal cortex is safe and 
      efficacious for major depressive disorder through a safety and feasibility study. 
      METHODS: Twelve patients were recruited in this randomized, single-blind, 
      sham-controlled study with a 104-week follow-up period. The main outcome measures 
      were Hamilton Depression Rating Scale-28 (HDRS), Montgomery-Asberg Depression 
      Rating Scale (MADRS), Global Assessment of Function (GAF), and Quality of Life 
      Enjoyment and Satisfaction (QLES) questionnaire. An electrode was implanted over 
      Brodmann area 9/46 in the left hemisphere. The electrode provided long-term 
      stimulation to this target via its connections to an implanted neurostimulator in 
      the chest. RESULTS: During the sham-controlled phase, there was no statistical 
      difference between sham and active stimulation, although a trend toward efficacy 
      was seen with the active stimulation group. In the open-label phase, we observed 
      a significant improvement in outcome scores for the HDRS, MADRS, and GAF but not 
      the QLES (HDRS: df = 7, F = 7.72, P < .001; MADRS: df = 7, F = 8.2, P < .001; 
      GAF: df = 5, F = 16.87, P < .001; QLES: df = 5, F = 1.32, P > .2; repeated 
      measures ANOVA). With regard to the HDRS, 6 patients had >/= 40% improvement, 5 
      patients had >/= 50% improvement, and 4 subjects achieved remission (HDRS < 10) at 
      some point during the study. CONCLUSION: Epidural cortical stimulation of the 
      left dorsolateral prefrontal cortex appears to be a safe and potentially 
      efficacious neuromodulation approach for treatment-refractory major depressive 
      disorder.
FAU - Kopell, Brian Harris
AU  - Kopell BH
AD  - Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin 
      53226, USA. bkopell@mcw.edu
FAU - Halverson, Jerry
AU  - Halverson J
FAU - Butson, Christopher R
AU  - Butson CR
FAU - Dickinson, Mercedes
AU  - Dickinson M
FAU - Bobholz, Julie
AU  - Bobholz J
FAU - Harsch, Harold
AU  - Harsch H
FAU - Rainey, Charles
AU  - Rainey C
FAU - Kondziolka, Douglas
AU  - Kondziolka D
FAU - Howland, Robert
AU  - Howland R
FAU - Eskandar, Emad
AU  - Eskandar E
FAU - Evans, Karleyton C
AU  - Evans KC
FAU - Dougherty, Darin D
AU  - Dougherty DD
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - Neurosurgery
JT  - Neurosurgery
JID - 7802914
SB  - IM
CIN - Neurosurgery. 2012 Jan;70(1):E268-9; author reply E269. PMID: 21968383
MH  - Adult
MH  - Depressive Disorder, Major/diagnostic imaging/physiopathology/*therapy
MH  - Electric Stimulation Therapy/adverse effects/instrumentation/*methods
MH  - Feasibility Studies
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prefrontal Cortex/*physiology/surgery
MH  - Prospective Studies
MH  - Radionuclide Imaging
MH  - Single-Blind Method
EDAT- 2011/06/29 06:00
MHDA- 2012/08/11 06:00
CRDT- 2011/06/29 06:00
PHST- 2011/06/29 06:00 [entrez]
PHST- 2011/06/29 06:00 [pubmed]
PHST- 2012/08/11 06:00 [medline]
AID - 10.1227/NEU.0b013e318229cfcd [doi]
PST - ppublish
SO  - Neurosurgery. 2011 Nov;69(5):1015-29; discussion 1029. doi: 
      10.1227/NEU.0b013e318229cfcd.