Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

Obsessive-compulsive Disorder (OCD) Clinical Trial

— NEP-TOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605316
• Other study ID #: RECHMPL18_0141
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: April 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 30, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Obsessive-Compulsive Disorder
• Obsessive-compulsive Disorder (OCD)

Intervention

Procedure:
• Deep brain stimulation (DBS)
Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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