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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Procedure: Standard technique; Procedure: Micro-assisted technique

• Registration Number: NCT02377375
• Lead Sponsor: Universitaire Ziekenhuizen KU 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-27
• Study First Submitted QC: 2015-02-25
• Study First Posted: 2015-03-03
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard	Standard technique	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.
Micro-assisted	Micro-assisted technique	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.

Primary Outcome Measures

Name	Time	Method
Millimeter difference in position between planned and actual target	4 weeks after surgery

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium