Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

Completed

• Conditions: Obsessive-compulsive Disorder (OCD)

• Registration Number: NCT03605316
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2018-04
• Study Start: 2018-04-01
• Study First Submitted: 2018-04-13
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-30
• Study First Submitted QC: 2018-07-27
• Last Update Submitted: 2018-07-27
• Study First Posted: 2018-07-30
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)	12 months	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

Secondary Outcome Measures

Name	Time	Method
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).	12 months	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.

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France