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

February 9, 2021 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
        • Recruiting
        • Hospital de Clínicas de Porto Alegre
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Lucas Lovato, M.D.; M.Sc.
        • Sub-Investigator:
          • Fabiane Caillava, M.Sc.
        • Sub-Investigator:
          • Paulo Oppitz, M.D.
        • Sub-Investigator:
          • Paulo Ferreira, M.D.
        • Principal Investigator:
          • Marcelo Sousa, M.D.; M.Sc.
        • Principal Investigator:
          • Paulo Abreu, M.D.; Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 16, 2015

First Posted (Estimate)

July 17, 2015

Study Record Updates

Last Update Posted (Actual)

February 12, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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