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

Primary Purpose

OCD, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Radiosurgery
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OCD focused on measuring OCD, Neurosurgery, Radiosurgery

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Clínicas de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Radiosurgery by linear accelerator.

Outcomes

Primary Outcome Measures

Change in OCD symptoms
Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2015
Last Updated
February 9, 2021
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02500888
Brief Title
Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 30, 2015 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OCD, Quality of Life
Keywords
OCD, Neurosurgery, Radiosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Radiosurgery by linear accelerator.
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Intervention Description
Only one radiation session of about 180 Gy in bilateral internal capsule.
Primary Outcome Measure Information:
Title
Change in OCD symptoms
Description
Application of Yale-Brown Obsessive-Compulsive Scale (Y-Bocs) scale
Time Frame
Every 3 months until 12 months
Secondary Outcome Measure Information:
Title
Change in quality of life.
Description
Application of "Medical Outcomes Study 36-Item Short-Form Health Survey" (SF-36) scale
Time Frame
Every 3 months until 12 months
Title
Change in brain-derived neurotrophic factor (BDNF) blood dosing
Description
Serological blood tests
Time Frame
12 months
Title
Change in psychological tests
Description
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
Time Frame
12 months
Title
Side effects and complications
Description
Application of "Systematic Assessment for Treatment Emergent Effects" (SAFTEE) Event List and Interview.
Time Frame
Every 3 months until 12 months
Title
Change in familial accommodation
Description
Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS)
Time Frame
Every 3 months until 12 months
Title
Change in anxiety symptoms.
Description
Application of "Beck Anxiety Inventory" (BAI) scale
Time Frame
Every 3 months until 12 months
Title
Change in depressive symptoms.
Description
Application of "Beck Depression Inventory" (BDI) scale
Time Frame
Every 3 months until 12 months
Title
Change in near-infrared spectroscopy (NIRS) brain blood flow
Description
During application of Stroop psychological test.
Time Frame
12 months
Title
Change in OCD symptoms by CPRS
Description
Application of "Comprehensive Psychopathological Rating Scale" (CPRS)
Time Frame
Every 3 months
Title
Change in OCD symptoms by NIMH.
Description
Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale)
Time Frame
Every 3 months
Title
Change in Global Functioning
Description
Application of "Global Assessment of Functioning Scale" (GAF)
Time Frame
Every 3 months until 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paulo Abreu, M.D.; Ph.D.
Phone
555133598294
Email
paulo.abreu@ufrgs.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Sousa, M.D.; M.Sc
Phone
555199557634
Email
mbsousa@hcpa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paulo Abreu, M.D.; Ph.D.
Organizational Affiliation
Professor of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035903
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Abreu, M.D.; Ph.D.
Phone
555133598294
Email
paulo.abreu@ufrgs.br
First Name & Middle Initial & Last Name & Degree
Marcelo Sousa, M.D.; M.Sc.
Phone
555199557634
Email
mbsousa@hcpa.edu.br
First Name & Middle Initial & Last Name & Degree
Lucas Lovato, M.D.; M.Sc.
First Name & Middle Initial & Last Name & Degree
Fabiane Caillava, M.Sc.
First Name & Middle Initial & Last Name & Degree
Paulo Oppitz, M.D.
First Name & Middle Initial & Last Name & Degree
Paulo Ferreira, M.D.
First Name & Middle Initial & Last Name & Degree
Marcelo Sousa, M.D.; M.Sc.
First Name & Middle Initial & Last Name & Degree
Paulo Abreu, M.D.; Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluation of Capsulotomy by Linear Accelerator Radiosurgery in Severe and Refractory Obsessive-compulsive Disorder

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