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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Micro-assisted technique
Standard technique
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Deep Brain Stimulation, OCD

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UZ LeuvenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Micro-assisted

Standard

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Millimeter difference in position between planned and actual target

Secondary Outcome Measures

Full Information

First Posted
January 27, 2015
Last Updated
January 26, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT02377375
Brief Title
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision
Official Title
Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Deep Brain Stimulation, OCD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micro-assisted
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Micro-assisted technique
Intervention Description
Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670
Intervention Type
Procedure
Intervention Name(s)
Standard technique
Intervention Description
Medtronic DBS lead 3391-28cm
Primary Outcome Measure Information:
Title
Millimeter difference in position between planned and actual target
Time Frame
4 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bart Nuttin, MD, PHD
Phone
003216340859
Email
bart.nuttin@kuleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Simon Raymaekers, MD
Phone
003216342690
Email
simon.raymaekers@uzleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bart Nuttin, MD, PHD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
23268197
Citation
Nuttin B, Gielen F, van Kuyck K, Wu H, Luyten L, Welkenhuysen M, Brionne TC, Gabriels 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.
Results Reference
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Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD): Improving Targeting Precision

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