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Trial record 2 of 35 for:    deep brain stimulation OCD

Deep Brain Stimulation for Severe Obsessive Compulsive Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT02655926
First received: July 17, 2015
Last updated: January 12, 2016
Last verified: July 2015
  Purpose
The overarching aim is to compare the effects of ventral capsule/ventral striatum (VC/VS) and subthalamic nucleus (STN) deep brain stimulation (DBS) in the same participants. Investigators will test the hypothesis, grounded in cognitive neuroscience, that DBS at both sites is better than either site alone for treating the symptom dimensions of obsessive compulsive disorder (OCD). Specifically, Investigators will employ novel cognitive paradigms and neurophysiological measures of cortical synaptic function to test the hypothesis that VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms is mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting obsessions and compulsions with STN DBS. Investigators will additionally determine whether adjunctive cognitive behavioural therapy (CBT) enhances the response to DBS by providing the cognitive and behavioural skills to optimise symptom management and daily function.

Condition Intervention
Obsessive-Compulsive Disorder
Procedure: Deep Brain Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Deep Brain Stimulation for Severe Obsessive Compulsive Disorder: Efficacy and Mechanisms of Ventral Striatum and Subthalamic Nucleus Targets

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Improvement of OCD symptoms on YBOCS scale greater than or equal to 35% [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: September 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: STN Arm
Participants would only have STN deep brain stimulation switched at optimal settings for that participant on for 12 weeks.
Procedure: Deep Brain Stimulation
Participants undergo implantation of bilateral electrodes at both the VS/VC and STN sites through a single burr hole under general anaesthesia. High-resolution MRI scans are used to calculate target coordinates and to verify accurate electrode location post-surgery. Each STN electrode have 4 electrical contacts at its distal tip (with a 0.5mm separation) and each VS/VC electrode have 4 electrical contacts at its distal tip (with a 1.5mm separation) to allow fine tuning of the exact site for stimulation delivery. Two non-rechargeable batteries (Activa PC) are connected to the electrodes and positioned under the skin of the right and left chest wall so that they correspond to the same set of electrodes for each patient: one for the 2 STN electrodes and one for the 2 VC/VS electrodes.
Other Name: DBS
Active Comparator: VC/VS Arm
Participants would only have VC/VS deep brain stimulation switched on at optimal settings for that participant for 12 weeks.
Procedure: Deep Brain Stimulation
Participants undergo implantation of bilateral electrodes at both the VS/VC and STN sites through a single burr hole under general anaesthesia. High-resolution MRI scans are used to calculate target coordinates and to verify accurate electrode location post-surgery. Each STN electrode have 4 electrical contacts at its distal tip (with a 0.5mm separation) and each VS/VC electrode have 4 electrical contacts at its distal tip (with a 1.5mm separation) to allow fine tuning of the exact site for stimulation delivery. Two non-rechargeable batteries (Activa PC) are connected to the electrodes and positioned under the skin of the right and left chest wall so that they correspond to the same set of electrodes for each patient: one for the 2 STN electrodes and one for the 2 VC/VS electrodes.
Other Name: DBS

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  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Participants must have undergone intensive treatment and have demonstrable treatment resistance as defined by:

    1. At least two serotonin reuptake inhibitors (SRI) for a minimum of 12 weeks at optimal British National Formulary (BNF) doses.
    2. Augmentation of SRI treatment with antipsychotic drugs administered at maximally tolerated doses or by extending the selective serotonin reuptake inhibitor (SSRI) dose beyond BNF limits.
    3. Two trials of CBT of at least 10 hours.
    4. Failed inpatient treatment for OCD.
  2. Participants must be older than 20 years of age.
  3. Confirmation of a primary diagnosis of obsessive compulsive disorder (International Classification of Diseases (ICD 10) F42.0—F42.9).
  4. Duration of OCD of at least 10 years.
  5. At least 2 years of unremitting symptoms despite intensive psychopharmacological and psychological treatment or failure to sustain, over a 3 month period, a response to inpatient psychological treatment by at least 33% with accompanying optimised pharmacological therapy.
  6. A minimum score of 32 on Yale Brown Obsessive Compulsive Scale (YBOCS) thus constituting profound illness and a maximum score of 50 on the Diagnostic and Statistical Manual of Mental Disorders (DSM IV) General Assessment of Function Scale (GAF).
  7. Ability to provide sustained informed consent.

Exclusion Criteria:

  1. Current diagnosis of Substance misuse (ICD10 F10—F19)
  2. Current diagnosis of Organic brain syndrome (ICD10 F00—F09)
  3. Current diagnosis of Adult personality disorder (ICD10 F60—F69)
  4. Current diagnosis of Pervasive developmental disorder (ICD10 F84)
  5. Current diagnosis of Schizophrenia (ICD10 F20-F29)
  6. Current diagnosis of Bipolar disorder (ICD 10 F30-31)
  7. Contraindications to neurosurgery
  8. Pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02655926

Locations
United Kingdom
UCL Institute of Neurology
London, United Kingdom, WC1N 3BG
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Eileen M Joyce, PhD University College, London
  More Information

Publications:

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02655926     History of Changes
Other Study ID Numbers: 12/0226  MR/J012009/1  12/LO/1087  105869  18430630 
Study First Received: July 17, 2015
Last Updated: January 12, 2016
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University College, London:
OCD
DBS
Deep Brain Stimulation

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Compulsive Behavior
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Impulsive Behavior

ClinicalTrials.gov processed this record on September 30, 2016