Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

NCT ID: NCT03605316

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-06-30

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.

Conditions

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Obsessive-compulsive Disorder (OCD)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Deep brain stimulation (DBS)

Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabienne CYPRIEN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL18_0141

Identifier Type: -

Identifier Source: org_study_id

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