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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 : Recruiting
First Posted : March 3, 2015
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Procedure: Micro-assisted technique Procedure: Standard technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Procedure: Micro-assisted technique
Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670

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.
Procedure: Standard technique
Medtronic DBS lead 3391-28cm




Primary Outcome Measures :
  1. Millimeter difference in position between planned and actual target [ Time Frame: 4 weeks after surgery ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02377375


Contacts
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Contact: Bart Nuttin, MD, PHD 003216340859 bart.nuttin@kuleuven.be
Contact: Simon Raymaekers, MD 003216342690 simon.raymaekers@uzleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Bart Nuttin, MD, PHD UZ Leuven

Publications:
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02377375     History of Changes
Other Study ID Numbers: S57471
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Universitaire Ziekenhuizen Leuven:
Deep Brain Stimulation
OCD
Additional relevant MeSH terms:
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Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders