NCT02433886

Efficacy and Adverse Events of Bilateral Single-shot VC/VS Gamma Capsulotomy for OCD: a Pilot Study

Efficacy and Adverse Events of Bilateral Single-shot Ventral Capsular/Ventral Striatal Gamma Capsulotomy for Obsessive-compulsive Disorder: a Pilot Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (estimated)
• Sponsor: University of Sao Paulo General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Up to 40% of Obsessive-Compulsive Disorder (OCD) patients do not respond to conventional treatments (medications or behavior therapy). For some of them, a neurosurgical treatment can be indicated. A previous study, employing bilateral double-shot ventral capsular/ventral striatal (VC/VS) Gamma capsulotomy (GVC) for OCD has shown that this radiosurgical technique is potentially efficacious and relatively safe. However, a few patients may develop complications associated to radionecrosis (eg., brain cysts) in a long-term follow-up, which are probably associated to lesion volumes. Another study, with the preliminary results of smaller VC/VS Gamma capsulotomy lesions has suggested that this procedure is safe and remains efficacious. Our aim is to investigate the efficacy and safety profiles of smaller, single-shot VC/VS Gamma capsulotomy for OCD. This study will support the development of a future double-blind, randomized clinical trial of single-shot VC/VS Gamma capsulotomy.

Conditions

• Obsessive-compulsive Disorder

Interventions

Type	Name	Description
PROCEDURE	Gamma Ventral Capsulotomy

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-12-01
• Completion: 2020-12-01
• First posted: 2015-05-05
• Last updated: 2015-05-05

Locations

1 site across 1 country: Brazil