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Deep Electrical Neuromodulation in Obsessive-compulsive Disorder

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03605316
Acronym
NEP-TOC
Enrollment
6
Registered
2018-07-30
Start date
2018-04-01
Completion date
2018-06-30
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive-compulsive Disorder (OCD)

Keywords

Deep brain stimulation, obsessive-compulsive disorder, neuromodulation, psychiatry, quality of life

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.

Interventions

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

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)Baseline10-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

MeasureTime frameDescription
Global Assessment of Functioning (GAF), axis V of the DSM-IV (APA, 1994).Baselinea 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026