Clinical trial NCT03605316: Deep Electrical Neuromodulation in Obsessive-compulsive Disorder
Official title: Electric Neuromodulation in Refractory Obsessive-compulsive Disorder : the Montpellier Experience (France)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessive-compulsive Disorder (OCD)
Keywords: Deep brain stimulation
obsessive-compulsive disorder
neuromodulation
psychiatry
quality of life
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2018-07-30
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Six patients consisting in three males and three females aged 18 years and over implanted at the University Hospital (CHU) of Montpellier (France) between June 2003 and February 2013.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: Baseline
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
timeFrame: 12 months
Secondary outcomes:
measure: Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
timeFrame: Baseline
measure: Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).
timeFrame: 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Fabienne CYPRIEN
role: PRINCIPAL_INVESTIGATOR
References: