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Deep Brain Stimulation for Severe Obsessive Compulsive Disorder

NCT02655926 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-03-03

No results posted yet for this study

Summary

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.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

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.

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Eileen M Joyce, PhD · University College, London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02655926 on ClinicalTrials.gov