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

Not Applicable

Recruiting

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Device: Deep Brain Stimulation

• Registration Number: NCT02844049
• Lead Sponsor: University Hospital, Grenoble

Brief 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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-26
• Study Start: 2016-09
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29
• Primary Completion: 2026-07
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• OCD for > 5 years
• YBOCS> 25 and/or YBOCS sub-scale >15
• GAF< 45
• 3 or more documented SRI trials, including clomipramine (10-12 weeks at adequate dose)
• SRI augmentation for > 4 weeks with at least one antipsychotic and with one of the following: lithium, clonazepam
• Adequate trial of CBT (Exposure Therapy and Response Prevention) (intolerance or >15 sessions)
• Ability to provide informed consent

Exclusion Criteria

• Hoarding (if the only OCD symptom)
• OCD with poor insight (BABS score > 12)
• Lifetime diagnosis of psychosis or bipolar disorder;
• Substance abuse or dependence within the previous six months;
• Baseline Montgomery and Asberg (MADRS) suicidality item (item 10) score >2;
• Current DSM-5 personality disorder of Cluster A (e.g., paranoid or schizotypal personality disorder) or B (e.g., borderline or antisocial personality disorder);
• Brain pathology, such as moderate or marked cerebral atrophy, stroke, tumor or previous neurosurgical procedures (i.e. capsulotomy etc), history of cognitive impairment and cognitive deterioration (Addenbrooke's Cognitive Examination ACE score of < 80).
• Contra-indications to surgery, anaesthesia, or MRI
• compulsory hospitalization/ care; pregnant or nursing patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep Brain Stimulation	Deep Brain Stimulation	DBS surgical procedure scheduled and realized

Primary Outcome Measures

Name	Time	Method
Assessment 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	1 year	QOL assessment : scores at SF36

Secondary Outcome Measures

Name	Time	Method
Psychiatric assessment n°5	1 year	clinical profile defined by score at STAI (State-Trait Anxiety Inventory)
Psychiatric assessment n°1	1 year	clinical profile defined by score at YBOCS -Yale Brown Obsessive Compulsive Scale
Psychiatric assessment n°2	1 year	clinical profile defined by score at DYBOCS- Dimensional Yale Brown Obsessive Compulsive Scale
Psychiatric assessment n°3	1 year	clinical profile defined by score at YMRS (Young Mania Rating Scale)
Psychiatric assessment n°4	1 year	clinical profile defined by score at HAMA (Hamilton Rating Scale for Anxiety)
Psychiatric assessment n°6	1 year	clinical profile defined by score at UPPS-P Impulsive Behavior Scale
Assessment of the suicidal risk under DBS+BMT vs BMT in resistant OCD	1 year	Measure of suicidal risk with MADRS scale
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°2	1 year	Functioning scores : WHODAS 2.0
Neuropsychological markers n°6	1 year	Score at URICA (University Rhode Island Change Assessment Scale)
Psychiatric assessment n°7	1 year	clinical profile defined by score at Clinical Global Impression (Severity of OCD)
Assessment of the impact of DBS+BMT versus BMT alone on a measure of Functioning score n°1	1 year	Functioning scores : GAF (Global assessment functioning scale)
side effects	1 year	Number of patients with side effects related to medical treatment, surgery and to stimulation
Psychiatric markers n°1	1 year	scores at Big Five Inventory
Psychiatric markers n°2	1 year	scores at BABS (BROWN ASSESSMENT OF BELIEFS SCALE)
Neurological markers n°3	1 year	score at UPDRS (Unified Parkinson's Disease Rating Scale)
Neuropsychological markers n°4	1 year	Score at OBQ-44 (Obsessive Beliefs Questionnaire)
Neuropsychological markers n°5	1 year	Score at MCQ (Metacognitions questionnaires)
Neuropsychological markers	1 year	Score at Addenbrooke Cognitive Examination (ACE) battery
Per-op electrophysiological mapping of the STN activity n°1	1 year	electrophysiological parameters at rest and during OCD provocative tests
Per-op electrophysiological mapping of the STN activity n°3	1 year	electrophysiological parameters at rest and during OCD emotional test
Per-op electrophysiological mapping of the STN activity n°2	1 year	electrophysiological parameters at rest and during OCD uncertainty test
Per-op electrophysiological mapping of the STN activity n°4	1 year	electrophysiological parameters at rest and during OCD cognitive and motor test

Trial Locations

Locations (8)

CHU Henri Mondor; 🇫🇷 Creteil, France

University Hospital of Grenoble Michallon; 🇫🇷 Grenoble, France

APHP La Pitié Salpêtrière; 🇫🇷 Paris, France

Universitätsklinikum Köln (AöR); 🇩🇪 Koln, Germany

Djurfeldt; 🇸🇪 Stockholm, Sweden

Chu Nice - Hopital Pasteur; 🇫🇷 Nice, France

Ghu Sainte Anne; 🇫🇷 Paris, France

Hôpitaux Universitaires de Genève; 🇨🇭 Geneve, Switzerland