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Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision

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ClinicalTrials.gov Identifier: NCT02377375
Recruitment Status : Unknown
Verified January 2016 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date  ICMJE January 27, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE January 2015
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Millimeter difference in position between planned and actual target [ Time Frame: 4 weeks after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision
Official Title  ICMJE Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
Brief Summary When comparing targeting precision between DBS in parkinsonian patients and OCD patients, an unexpected deviation from the planned targets was discovered in OCD patients (Nuttin et al., 2013). The objective of this trial is to investigate whether the use of a micro-electrode assisted technique improves targeting precision in DBS at the BNST.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Procedure: Micro-assisted technique
    Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670
  • Procedure: Standard technique
    Medtronic DBS lead 3391-28cm
Study Arms  ICMJE
  • Experimental: Micro-assisted
    In each patient, one electrode will be implanted using the standard technique and one electrode will be implanted using the micro-electrode assisted technique. The side is randomized.
    Intervention: Procedure: Micro-assisted technique
  • Active Comparator: Standard
    In each patient, one electrode will be implanted using the standard technique and one electrode will be implanted using the micro-electrode assisted technique. The side is randomized.
    Intervention: Procedure: Standard technique
Publications * Nuttin B, Gielen F, van Kuyck K, Wu H, Luyten L, Welkenhuysen M, Brionne TC, Gabriëls L. Targeting bed nucleus of the stria terminalis for severe obsessive-compulsive disorder: more unexpected lead placement in obsessive-compulsive disorder than in surgery for movement disorders. World Neurosurg. 2013 Sep-Oct;80(3-4):S30.e11-6. doi: 10.1016/j.wneu.2012.12.029. Epub 2012 Dec 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD (300.3).
  • Failure of documented trials of pharmacotherapy, following an appropriate treatment algorithm for OCD.
  • Failure of documented trial of cognitive and behavioural therapy
  • Duration of illness: min. 5 year
  • Y-BOCS (Yale-Brown Obsessive Compulsive Scale) at least 30/40.
  • Age: 20-65 year

Exclusion Criteria:

  • DSM-IV diagnosis on axis 2 of severe personality disorder in cluster A or B, especially in the case of heightened risk for acting-out behavior.
  • DSM-IV diagnosis on axis 3 of organic brain pathology or significant abnormalities on MRI.
  • Present or past history of psychotic symptoms.
  • Present substance abuse, or instable remission of substance abuses (i.e. no substance abuse during the last 12 months).
  • Any disorder affecting cognitive functioning, other than motor tics and Gilles de la Tourette's Syndrome
  • Mental retardation. A minimum threshold of cognitive skills is needed for adequate reporting on questionnaires and evaluation, and for technical handling of the instruments in a later faze.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02377375
Other Study ID Numbers  ICMJE S57471
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Universitaire Ziekenhuizen Leuven
Study Sponsor  ICMJE Universitaire Ziekenhuizen Leuven
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bart Nuttin, MD, PHD UZ Leuven
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP