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

Obsessive-Compulsive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02377375
• Other study ID #: S57471
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2015
• Last updated: January 26, 2016
• Start date: January 2015

Study information

• Verified date: January 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Bart Nuttin, MD, PHD
• Phone: 003216340859
• Email: bart.nuttin[@]kuleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder

Intervention

Procedure:
• Micro-assisted technique
Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670
• Standard technique
Medtronic DBS lead 3391-28cm

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Nuttin B, Gielen F, van Kuyck K, Wu H, Luyten L, Welkenhuysen M, Brionne TC, Gabriëls 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Millimeter difference in position between planned and actual target		4 weeks after surgery	No