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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Micro-assisted technique

Intervention Type PROCEDURE

Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670

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.

Group Type ACTIVE_COMPARATOR

Standard technique

Intervention Type PROCEDURE

Medtronic DBS lead 3391-28cm

Interventions

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Micro-assisted technique

Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670

Intervention Type PROCEDURE

Standard technique

Medtronic DBS lead 3391-28cm

Intervention Type PROCEDURE

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No