Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

Study Overview
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Brief Summary
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Obsessive-compulsive disorder (OCD) is a neuropsychiatric disease characterised by intrusive, recurrent and persistent thoughts, urges or images (obsessions) and the resulting excessive repetitive behaviours or mental acts according to rigid rules unrealistically aimed at reducing distress (compulsions). Its lifetime prevalence in the general population is usually estimated between 1 - 3% (Ruscio, Mol Psychiatry, 2010). Despite appropriate pharmacological and cognitive-behavioural treatments, it is commonly estimated that 10% of patients are therapy-refractory and that among improved or recovered patients, sustained efficacy is uncertain. For treatment refractory OCD patients, a neurosurgical treatment by deep brain stimulation (DBS), has emerged in the late 1990s as a new therapeutic option (Nuttin et al, Lancet, 1999). The objective of the current study is to report the long-term treatment effects (safety and effectiveness) of DBS from the cohort of six severe and therapy-refractory OCD patients implanted at the French university hospital of Montpellier since 2003.

Detailed Description
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The data needed to carry out the study will be extracted from the medical files of the 6 patients concerned. The following data will be collected: Age, sex Medical, surgical and psychiatric history History of pharmacological treatments Elements from clinical examination any reported adverse effect scores of the various questionnaires completed throughout the follow-up (including Y-BOCS and GAF) results of biological, morphological, neuropsychological tests Stimulation parameters applied since implantation.

Official Title
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Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)

Conditions
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Obsessive-compulsive Disorder (OCD)

Intervention / Treatment
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* Procedure: Deep brain stimulation (DBS)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: all patients with severe and refractory OCD according to DSM-IV criteria, confirmed by experienced psychiatrist treated by DBS at the CHU of Montpellier Exclusion criteria: - already enrolled in a study protocol at time of implantation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Deep brain stimulation (DBS)|Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | 10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS | Baseline | 
| Yale-Brown Obsessive Compulsive Scale (Y-BOCS) | 10-item scale with scores ranging from 0 to 40; higher scores indicating more severe OCD symptoms. Patients are defined as responders if they have a score decrease of at least 35% on the Y-BOCS | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994). | a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms. | Baseline | 
| Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994). | a rating scale used to subjectively assess the social and occupational functioning as well as psychological symptoms of adults. The scale ranges from 1 to 100, divided into 10-point intervals describing the level of functioning and symptoms. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep brain stimulation, obsessive-compulsive disorder, neuromodulation, psychiatry, quality of life