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.
The study will focus on an innovative therapeutic strategy (DBS) and on an original objective, quality of life, which is considered to better reflect the impact of a therapeutic strategy. Moreover, the study will help to define the predictive biomarkers /biosignatures of response to STN DBS in OCD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
surgical procedure
CHU Henri Mondor
Créteil, France
COMPLETEDUniversity Hospital of Grenoble Michallon
Grenoble, France
RECRUITINGChu Nice - Hopital Pasteur
Nice, France
RECRUITINGAPHP La Pitié Salpêtrière
Paris, France
RECRUITINGGhu Sainte Anne
Paris, France
RECRUITINGUniversitätsklinikum Köln (AöR)
Cologne, Germany
RECRUITINGDjurfeldt
Stockholm, Sweden
RECRUITINGHôpitaux Universitaires de Genève
Geneva, Switzerland
RECRUITINGAssessment of the impact of DBS+BMT versus BMT alone on a measure of Quality of life in resistant OCD patients at 1-year follow-up
QOL assessment : scores at SF36
Time frame: 1 year
Psychiatric assessment n°1
clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale
Time frame: 1 year
Psychiatric assessment n°2
clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale
Time frame: 1 year
Psychiatric assessment n°3
clinical profile defined by score at YMRS (Young Mania Rating Scale)
Time frame: 1 year
Psychiatric assessment n°4
clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)
Time frame: 1 year
Psychiatric assessment n°5
clinical profile defined by score at STAI (State-Trait Anxiety Inventory)
Time frame: 1 year
Psychiatric assessment n°6
clinical profile defined by score at UPPS-P Impulsive Behavior Scale
Time frame: 1 year
Psychiatric assessment n°7
clinical profile defined by score at Clinical Global Impression (Severity of OCD)
Time frame: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1
Functioning scores : GAF (Global assessment functioning scale)
Time frame: 1 year
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2
Functioning scores : WHODAS 2.0
Time frame: 1 year
side effects
Number of patients with side effects related to medical treatment, surgery and to stimulation
Time frame: 1 year
Psychiatric markers n°1
scores at Big Five Inventory
Time frame: 1 year
Psychiatric markers n°2
scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)
Time frame: 1 year
Neurological markers n°3
score at UPDRS (Unified Parkinson's Disease Rating Scale)
Time frame: 1 year
Neuropsychological markers n°4
Score at OBQ-44 (Obsessive Beliefs Questionnaire)
Time frame: 1 year
Neuropsychological markers n°5
Score at MCQ (Metacognitions questionnaires)
Time frame: 1 year
Neuropsychological markers n°6
Score at URICA (University Rhode Island Change Assessment Scale)
Time frame: 1 year
Neuropsychological markers
Score at Addenbrooke Cognitive Examination (ACE) battery
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°1
electrophysiological parameters at rest and during OCD provocative tests
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°2
electrophysiological parameters at rest and during OCD uncertainty test
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°3
electrophysiological parameters at rest and during OCD emotional test
Time frame: 1 year
Per-op electrophysiological mapping of the STN activity n°4
electrophysiological parameters at rest and during OCD cognitive and motor test
Time frame: 1 year
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD
Measure of suicidal risk with MADRS scale
Time frame: 1 year
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