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

• Sponsor: Hospital de Clinicas de Porto Alegre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02500888
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 84
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
OCD; Quality of Life	Radiation: Radiosurgery	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Jun 30, 2015
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Radiosurgery by linear accelerator.	Radiation: Radiosurgery; Only one radiation session of about 180 Gy in bilateral internal capsule.

Outcome Measures

Primary Outcome Measures

1. Change in OCD symptoms [Every 3 months until 12 months]

   Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale

Secondary Outcome Measures

1. 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

2. Change in brain-derived neurotrophic factor (BDNF) blood dosing [12 months]

   Serological blood tests

3. 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

4. Side effects and complications [Every 3 months until 12 months]

   Application of "Systematic Assessment for Treatment Emergent Effects" (SAFTEE) Event List and Interview.

5. Change in familial accommodation [Every 3 months until 12 months]

   Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS)

6. Change in anxiety symptoms. [Every 3 months until 12 months]

   Application of "Beck Anxiety Inventory" (BAI) scale

7. Change in depressive symptoms. [Every 3 months until 12 months]

   Application of "Beck Depression Inventory" (BDI) scale

8. Change in near-infrared spectroscopy (NIRS) brain blood flow [12 months]

   During application of Stroop psychological test.

9. Change in OCD symptoms by CPRS [Every 3 months]

   Application of "Comprehensive Psychopathological Rating Scale" (CPRS)

10. Change in OCD symptoms by NIMH. [Every 3 months]

    Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale)

11. Change in Global Functioning [Every 3 months until 12 months]

    Application of "Global Assessment of Functioning Scale" (GAF)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul	Brazil	90035903

Sponsors and Collaborators

• Hospital de Clinicas de Porto Alegre

Investigators

• Principal Investigator: Paulo Abreu, M.D.; Ph.D., Professor of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

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• Responsible Party: Hospital de Clinicas de Porto Alegre
• ClinicalTrials.gov Identifier: NCT02500888
• Other Study ID Numbers: 14-0341
• First Posted: Jul 17, 2015
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Hospital de Clinicas de Porto Alegre: OCD; Neurosurgery; Radiosurgery
• Additional relevant MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder

Study Results

No Results Posted as of Feb 12, 2021