Gamma Ventral Capsulotomy For Refractory Obsessive-compulsive Disorder: Preliminary Findings Of A Double-blind, Randomized Controlled TrialCarlos Antonio Lopes1, Douglas G Castro2, Miguel M Canteras2, Marcelo Batistuzzo1, Anita Taub1, Carina C DAlcante1, Benjamin D Greenberg3, Georg Norén4, Eurípedes C Miguel11Department of Psychiatry 2 Institute of Neurological Radiosurgery 3 Department of Psychiatry and Human Behavior 4 Department of Clinical Neurosciences - Neurosurgery Keywords: obsessive-compulsive disorder, radiosurgery, gamma knife, outcome, techniqueInteractive ManuscriptAsk Questions of this Manuscript: What is the background behind your study?Up to 40 % of Obsessive-Compulsive Disorder (OCD) patients remain refractory to conventional treatments. For them, an improved, Gamma Knife radiosurgery (Gamma ventral capsulotomy - GVC) was recently developed. What is the purpose of your study?We report the results from a pilot study with this technique, as well as from the first double-blind, randomized controlled trial (DB-RCT) of its kind. Describe your patient group.Twenty one refractory OCD patients were selected. The first five patients were included in a pilot study. The other 16 subjects randomly received either active (8 patients) or “sham” (7 patients) radiosurgery, as a DB-RCT. One patient remains under blind condition. Describe what you did.Double-shot, 4 mm collimator lesions were produced at the ventral portions of the anterior limb of the internal capsule. Psychopathological, clinical, and neuropsychological assessments and magnetic resonance scans were provided pre and post-operatively. Describe your main findings.One to five years of follow-up assessments are available. Three out of five patients (60%) from the pilot study and three out of eight patients (37.5%) from the blind active group became responders. As a whole, six out of thirteen (46 %) patients who received active radiosurgery responded, while no patients of the sham group responded, for 12 months of blind follow-up. Statistically significant differences between active and sham groups were observed for OCD symptoms scores (non-parametric analysis of variance, QW=6.760, 1 d.f.., p=0.0093). Mania, delirium, episodic headaches, dizziness, nausea were few times observed. One patient presented a cyst and a floating course of cognitive changes. No other adverse neuropsychological or personality changes were observed. Describe the main limitation of this study.This is a retrospective study. Describe your main conclusion.Preliminary findings indicate that GVC for OCD shows some efficacy. Describe the importance of your findings and how they can be used by others.There were relatively few adverse effects. Up to 40 % of Obsessive-Compulsive Disorder (OCD) patients remain refractory to conventional treatments. For them, an improved, Gamma Knife radiosurgery (Gamma ventral capsulotomy - GVC) was recently developed. We report the results from a pilot study with this technique, as well as from the first double-blind, randomized controlled trial (DB-RCT) of its kind. Twenty one refractory OCD patients were selected. The first five patients were included in a pilot study. The other 16 subjects randomly received either active (8 patients) or “sham” (7 patients) radiosurgery, as a DB-RCT. One patient remains under blind condition. Double-shot, 4 mm collimator lesions were produced at the ventral portions of the anterior limb of the internal capsule. Psychopathological, clinical, and neuropsychological assessments and magnetic resonance scans were provided pre and post-operatively. One to five years of follow-up assessments are available. Three out of five patients (60%) from the pilot study and three out of eight patients (37.5%) from the blind active group became responders. As a whole, six out of thirteen (46 %) patients who received active radiosurgery responded, while no patients of the sham group responded, for 12 months of blind follow-up. Statistically significant differences between active and sham groups were observed for OCD symptoms scores (non-parametric analysis of variance, QW=6.760, 1 d.f.., p=0.0093). Mania, delirium, episodic headaches, dizziness, nausea were few times observed. One patient presented a cyst and a floating course of cognitive changes. No other adverse neuropsychological or personality changes were observed. This is a retrospective study. Preliminary findings indicate that GVC for OCD shows some efficacy. There were relatively few adverse effects. Project Roles:
C. Lopes (), D. Castro (), M. Canteras (), M. Batistuzzo (), A. Taub (), C. DAlcante (), B. Greenberg (), G. Norén (), E. Miguel ()
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