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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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OCD, Quality of Life

Intervention / Treatment
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* Radiation: Radiosurgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Duration of OCD symptoms of at least five years. 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). Fill up the criteria for refractory to prior treatments. 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: History of head trauma or post-traumatic amnesia. Background of systemic or neurological diseases with brain impairment, severe and active. 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. pregnancy or lactation. Refusal to submit to the radiosurgical procedure. Refusal to accept the informed consent form, or participate. History of mental retardation and / or inability to understand the informed consent, confirmed by neuropsychological tests of the initial evaluation. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Radiosurgery by linear accelerator. | Radiation: Radiosurgery<br>* Only one radiation session of about 180 Gy in bilateral internal capsule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in OCD symptoms | Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale | Every 3 months until 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life. | Application of Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) scale | Every 3 months until 12 months | 
| Change in brain-derived neurotrophic factor (BDNF) blood dosing | Serological blood tests | 12 months | 
| Change in psychological tests | 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 | 12 months | 
| Side effects and complications | Application of Systematic Assessment for Treatment Emergent Effects (SAFTEE) Event List and Interview. | Every 3 months until 12 months | 
| Change in familial accommodation | Application of Family Accommodation Scale for Obsessive-Compulsive Disorder (FAS) | Every 3 months until 12 months | 
| Change in anxiety symptoms. | Application of Beck Anxiety Inventory (BAI) scale | Every 3 months until 12 months | 
| Change in depressive symptoms. | Application of Beck Depression Inventory (BDI) scale | Every 3 months until 12 months | 
| Change in near-infrared spectroscopy (NIRS) brain blood flow | During application of Stroop psychological test. | 12 months | 
| Change in OCD symptoms by CPRS | Application of Comprehensive Psychopathological Rating Scale (CPRS) | Every 3 months | 
| Change in OCD symptoms by NIMH. | Application of National Institute of Mental Health Global Obsessive-Compulsive Scale (NIMH OCD Scale) | Every 3 months | 
| Change in Global Functioning | Application of Global Assessment of Functioning Scale (GAF) | Every 3 months until 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OCD, Neurosurgery, Radiosurgery