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

Study Overview
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Brief Summary
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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.

Official Title
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Deep Brain Stimulation (DBS) for Obsessive Compulsive Disorder (OCD) in the Bed Nucleus of the Stria Terminalis (BNST): Improving Targeting Precision

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Procedure: Micro-assisted technique
* Procedure: Standard technique


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micro-assisted<br>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<br>* Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670<br>|
| Active Comparator: Standard<br>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<br>* Medtronic DBS lead 3391-28cm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Millimeter difference in position between planned and actual target |  | 4 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, OCD