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Completed

NCT Number: NCT01985815

Refining the Target for Deep Brain Stimulation (DBS) in Severe, Treatment Refractory Obsessive Compulsive Disorder (OCD)

In select, therapy resistent patients with Obsessive Compulsive Disorder (OCD) Deep Brain Stimulation (DBS) has been used as a treatment. DBS is a therapy modality in which electrodes are implanted within specific sub-structures of the brain in order to modulate the activity in targeted neural circuits associated with different neurological disorders. The results of this novel approach to psychiatric disorders have been optimistic. This study aims to investigate wether or not the distance to target location has an influence on the outcome.

In order to deliver DBS, leads containing four electrodes are implanted into the brain target in the ventral capsule/ventral striatum (VC/VS). After an optimization period, patients enter a triple blind randomised two fazed crossover design of two periods of three months. In both crossover branches, patients, evaluating psychiatrist and psychologist are blinded for the stimulation conditions. These conditions are stimulation ON (at optimal parameters) and stimulation OFF. Stimulation parameters are constant during the entire period. During the second crossover branch, stimulation conditions are reversed for all patients.

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Key information

Conditions

Obsessive-Compulsive Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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.
  • The patient must be juridical free.

Treatment and study plan

VC/VS stimulation

Device

Other names: Neurostimulator: Kinetra (Medtronic), Electrode: 3387 (Medtronic)

Primary outcomes

  1. Yale Brown Obsessive Compulsive Scale (Y-BOCS)

    Time frame: up to 12 months

Secondary outcomes

  1. Clinical Global Impression (CGI)

    Time frame: up to 12 months

  2. Global assessment of functioning (GAF)

    Time frame: up to 12 months

  3. Hamilton scale for anxiety

    Time frame: up to 12 months

  4. Beck depression inventory

    Time frame: up to 12 months

  5. Inventory of Depressive Symptoms (IDS)

    Time frame: up to 12 months

  6. Patient Global Impression (PGI).

    Time frame: up to 12 months

  7. Symptom Checklist (SCL-90)

    Time frame: up to 12 months

  8. Quality of Life and Satisfaction Questionnaire (Q-Les-Q)

    Time frame: up to 12 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
First posted
Nov 15, 2013
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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