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

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ClinicalTrials.gov Identifier: NCT02500888
Recruitment Status : Unknown
Verified March 2018 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Recruiting
First Posted : July 17, 2015
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
OCD Quality of Life Radiation: Radiosurgery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 30, 2015
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change in OCD symptoms [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 12 months ]
    Serological blood tests

  3. 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

  4. 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.

  5. Change in familial accommodation [ Time Frame: Every 3 months until 12 months ]
    Application of "Family Accommodation Scale for Obsessive-Compulsive Disorder" (FAS)

  6. Change in anxiety symptoms. [ Time Frame: Every 3 months until 12 months ]
    Application of "Beck Anxiety Inventory" (BAI) scale

  7. Change in depressive symptoms. [ Time Frame: Every 3 months until 12 months ]
    Application of "Beck Depression Inventory" (BDI) scale

  8. Change in near-infrared spectroscopy (NIRS) brain blood flow [ Time Frame: 12 months ]
    During application of Stroop psychological test.

  9. Change in OCD symptoms [ Time Frame: Every 3 months until 12 months ]
    Application of "Comprehensive Psychopathological Rating Scale" (CPRS)

  10. Change in OCD symptoms [ Time Frame: Every 3 months until 12 months ]
    Application of "USP-Sensory Phenomena Scale" (USP-SPS)

  11. Change in OCD symptoms [ Time Frame: Every 3 months until 12 months ]
    Application of "Brown Assessment of Beliefs Scale" (BABS)

  12. Change in OCD symptoms [ Time Frame: Every 3 months until 12 months ]
    Application of "National Institute of Mental Health Global Obsessive-Compulsive Scale" (NIMH OCD Scale)

  13. Change in Global Functioning [ Time Frame: Every 3 months until 12 months ]
    Application of "Global Assessment of Functioning Scale" (GAF)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500888


Contacts
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Contact: Paulo Abreu, M.D.; Ph.D. 555133598294 paulo.abreu@ufrgs.br
Contact: Marcelo Sousa, M.D.; M.Sc 555199557634 mbsousa@hcpa.edu.br

Locations
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Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
Contact: Paulo Abreu, M.D.; Ph.D.    555133598294    paulo.abreu@ufrgs.br   
Contact: Marcelo Sousa, M.D.; M.Sc.    555199557634    mbsousa@hcpa.edu.br   
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.         
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Paulo Abreu, M.D.; Ph.D. Professor of Medicine
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: July 17, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
OCD
Neurosurgery
Radiosurgery
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders