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

Not Applicable

• Conditions: OCD; Quality of Life
• Interventions: Radiation: Radiosurgery

• Registration Number: NCT02500888
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief 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.

Study Timeline

• Study Start: 2015-06-30
• Study First Submitted: 2015-07-09
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. OCD diagnosis, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) as a major disease entity. If comorbidity with other psychiatric or personality disorders, OCD symptoms dominate the clinical picture and precede other disorders.
2. Duration of OCD symptoms of at least five years.
3. Scores range of the obsessive-compulsive symptoms "Yale-Brown Obsessive-Compulsive Scale" (YBOCS) greater than 26 (or greater than 13, if obsessions or compulsions alone).
4. Fill up the criteria for refractory to prior treatments.
5. Be accepted by the method of "best estimate" for defining the patient is refractory, which consisted of confirmation by at least two specialists obsessive-compulsive disorder that the patient fulfills the criteria for effective refractory to previous treatments.

Exclusion Criteria

1. History of head trauma or post-traumatic amnesia.
2. Background of systemic or neurological diseases with brain impairment, severe and active.
3. History of current use of substances capable of inducing psychopathological manifestations, or signs of cumulative effects of alcohol or drugs in the central nervous system (such as cortical atrophy), confirmed by neuroimaging.
4. pregnancy or lactation.
5. Refusal to submit to the radiosurgical procedure.
6. Refusal to accept the informed consent form, or participate.
7. History of mental retardation and / or inability to understand the informed consent, confirmed by neuropsychological tests of the initial evaluation.
8. Lack of family or companion with proper capacity of understanding of the informed consent in patients with comorbid major depression or psychosis that could potentially have difficulty performing the appropriate judgment as to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Radiosurgery	Radiosurgery by linear accelerator.

Primary Outcome Measures

Name	Time	Method
Change in OCD symptoms	Every 3 months until 12 months	Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms.	Every 3 months until 12 months	Application of "Beck Depression Inventory" (BDI) scale
Change in quality of life.	Every 3 months until 12 months	Application of "Medical Outcomes Study 36-Item Short-Form Health Survey" (SF-36) scale
Change in brain-derived neurotrophic factor (BDNF) blood dosing	12 months	Serological blood tests
Side effects and complications	Every 3 months until 12 months	Application of "Systematic Assessment for Treatment Emergent Effects" (SAFTEE) Event List and Interview.
Change in near-infrared spectroscopy (NIRS) brain blood flow	12 months	During application of Stroop psychological test.
Change in familial accommodation	Every 3 months until 12 months	Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS)
Change in psychological tests	12 months	Application of: * Mini Mental Modified (3MS) test; * Wechsler of intelligence test; * Stroop of colors test; * Tracks tests A and B; * Boston Naming Test (BNT); * Wechsler Memory Scale Revised (WMS-R); * Wisconsin (WCST) test; * Brief Visual Memory Test (BVLT); * Hopkins Verbal Learning Test (HBLT) test; * Benton Line Orientation (BLO) test; * Grooved Pegboard Test; * Finger Tapping test; * Complex figure of Rey test
Change in OCD symptoms by NIMH.	Every 3 months	Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale)
Change in Global Functioning	Every 3 months until 12 months	Application of "Global Assessment of Functioning Scale" (GAF)
Change in anxiety symptoms.	Every 3 months until 12 months	Application of "Beck Anxiety Inventory" (BAI) scale
Change in OCD symptoms by CPRS	Every 3 months	Application of "Comprehensive Psychopathological Rating Scale" (CPRS)

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil