NCT02500888

Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder

Initial Evaluation of Efficacy and Adverse Events of Single Lesions in Bilateral Ventral-capsular and Ventral Capsulotomy-striatal by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Hospital de Clinicas de Porto Alegre · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate, through a pilot study with about ten cases, if bilateral ventral capsulotomy by linear accelerator enable modification of obsessive-compulsive symptoms and quality of life in patients with severe and refractory obsessive compulsive disorder (OCD) and also investigate possible adverse effects / complications of the procedure.

Detailed description

About ten patients with severe and refractory OCD will receive bilateral single lesions at the bottom of the anterior limb of the internal capsule by linear accelerator. Prior to the procedure, a detailed clinical and psychiatric evaluation, plus an extensive battery of psychiatric diagnostic tests, severity and progression of OCD, depression / anxiety symptoms, presence of tics, psychosocial impairment, quality of life, familial accommodation and neuropsychological and personality testes will be performed. Furthermore, the patients will be also assessed by serological and neuroimaging tests. The Individuals will be periodically evaluated and followed up for one year. The results of the scores of the rating scales will be analyzed and compared, as well as the profile of adverse events, cognitive or personality changes and improves in clinical tests and neuroimaging studies.

Conditions

• OCD
• Quality of Life

Interventions

Type	Name	Description
RADIATION	Radiosurgery	Only one radiation session of about 180 Gy in bilateral internal capsule.

Timeline

• Start date: 2015-06-30
• Primary completion: 2022-06-30
• Completion: 2022-06-30
• First posted: 2015-07-17
• Last updated: 2021-02-12

Locations

1 site across 1 country: Brazil