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RECRUITING
NCT02844049
NA

European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS

Sponsor: University Hospital, Grenoble

View on ClinicalTrials.gov

Summary

Obsessive-Compulsive Disorder (OCD) is among the most disabling psychiatric disorders as more than 40% of patients are resistant to the standard pharmacological and psychotherapy approaches and about 10% show severe disability and require institutionalization. These resistant patients may benefit from new surgical therapeutic approaches such as Deep Brain Stimulation (DBS) using high frequency stimulation of specific cerebral regions to modulate neural networks. Although promising, these results need nevertheless to be replicated and confirmed within a larger cohort of patients and considering a different main objective, instead of clinical improvement only. Indeed, despite a positive treatment response, adaptive functioning and quality of life may continue to be negatively impacted in OCD. Thus beyond symptom reduction, health-related quality of life (QoL) represents a more important objective of a treatment, as it includes both the individual's functional status and the individual's subjective perception of the impact of the illness on the patient's life. STN DBS induces significant clinical improvement, which may not be proportional to the QoL gain. Consequently, QoL appears to be a better outcome to target in the coming studies than clinical improvement alone. THe investigators thus propose a prospective study assessing the QoL changes of resistant OCD patients under STN DBS+BMT versus Best Medical Treatment (BMT) at 12 months, in order to assess the DBS induced gain in QoL in BMT-managed patients versus BMT alone.

Official title: European Study of Quality of Life in Resistant OCD Patients Treated by STN DBS Versus Best Medical Treatment

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2016-09

Completion Date

2027-04

Last Updated

2023-11-29

Healthy Volunteers

No

Interventions

DEVICE

Deep Brain Stimulation

surgical procedure

Locations (8)

CHU Henri Mondor

Créteil, France

University Hospital of Grenoble Michallon

Grenoble, France

Chu Nice - Hopital Pasteur

Nice, France

APHP La Pitié Salpêtrière

Paris, France

Ghu Sainte Anne

Paris, France

Universitätsklinikum Köln (AöR)

Cologne, Germany

Djurfeldt

Stockholm, Sweden

Hôpitaux Universitaires de Genève

Geneva, Switzerland