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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive-Compulsive Disorder
• Intervention / Treatment: Device: Deep Brain Stimulation

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sandra David-tchouda, MD; Phone Number: +33476767186; Email: SDavidTchouda@chugrenoble.fr
• Study Contact Backup: Name: Sandrine Massicot, Master; Phone Number: +33476768860; Email: smassicot@chu-grenoble.fr

Study Locations

• France
  • Creteil, France
    • Completed
    • Chu Henri Mondor
  • Grenoble, France
    • Recruiting
    • University Hospital of Grenoble Michallon
    • Contact: Mircea POLOSAN, MD PhD; Phone Number: 0033476765414; Email: MPolosan@chu-grenoble.fr
    • Principal Investigator: Mircea Polosan, MD PhD
    • Sub-Investigator: Stéphan Chabardès, MD PhD
    • Sub-Investigator: Anna Castrioto, MD
  • Nice, France
    • Recruiting
    • CHU Nice - Hôpital Pasteur
    • Contact: Denys FONTAINE, MD; Phone Number: 04 92 03 84 50; Email: fontaine.d@chu-nice.fr
    • Contact: Hélène BRUCKER; Phone Number: 04 92 03 75 57; Email: bruckert.h@chu-nice.fr
    • Principal Investigator: Denys FONTAINE, MD
    • Sub-Investigator: Bruno GIORDANA, MD
  • Paris, France
    • Recruiting
    • APHP La Pitié Salpêtrière
    • Contact: Bruno Millet, MD PhD; Phone Number: 33142162894; Email: b.millet@psl.aphp.fr
    • Sub-Investigator: Carine KARACHI, MD
    • Principal Investigator: Bruno MILLET, MD PhD
  • Paris, France
    • Recruiting
    • GHU Sainte Anne
    • Contact: Philippe DOMENECH, MD PhD; Email: philippe.domenech@ghu-paris.fr
    • Contact: Djamila KORICHE; Phone Number: 0145657665; Email: djamila.koriche@ghu-paris.fr
• Germany
  • Koln, Germany
    • Recruiting
    • Universitätsklinikum Köln (AöR)
    • Contact: Veerle VISSER-VANDEWALLE, MD; Phone Number: +49 221 478-82793; Email: veerle.visser-vandewalle@uk-koeln.de
    • Sub-Investigator: Jens KUHN, MD PhD
    • Principal Investigator: Veerle VISSER-VANDEWALLE, MD
• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Djurfeldt
    • Contact: Diana DJURFELDT, MD PhD; Phone Number: +46 72 211 9562; Email: diana.pascal@ki.se
    • Sub-Investigator: Diana DJURFELDT, MD PhD
    • Principal Investigator: Anders FYTAGORIDIS, MD PhD
• Switzerland
  • Geneve, Switzerland
    • Recruiting
    • Hopitaux Universitaires de Geneve
    • Contact: Joao FLORES, MD; Email: Joao.FloresAlvesDosSantos@hcuge.ch
    • Sub-Investigator: Shahan MOMJIAN, MD
    • Principal Investigator: Joao FLORES, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Deep Brain Stimulation; DBS surgical procedure scheduled and realized	Device: Deep Brain Stimulation; surgical procedure; Other Names: DBS
No Intervention: Control group; medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	QOL assessment : scores at SF36	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Mircea Polosan, MD PhD, University Hospital, Grenoble

Publications and helpful links

General Publications

• Subramaniam M, Soh P, Vaingankar JA, Picco L, Chong SA. Quality of life in obsessive-compulsive disorder: impact of the disorder and of treatment. CNS Drugs. 2013 May;27(5):367-83. doi: 10.1007/s40263-013-0056-z.
• Mallet L, Polosan M, Jaafari N, Baup N, Welter ML, Fontaine D, du Montcel ST, Yelnik J, Chereau I, Arbus C, Raoul S, Aouizerate B, Damier P, Chabardes S, Czernecki V, Ardouin C, Krebs MO, Bardinet E, Chaynes P, Burbaud P, Cornu P, Derost P, Bougerol T, Bataille B, Mattei V, Dormont D, Devaux B, Verin M, Houeto JL, Pollak P, Benabid AL, Agid Y, Krack P, Millet B, Pelissolo A; STOC Study Group. Subthalamic nucleus stimulation in severe obsessive-compulsive disorder. N Engl J Med. 2008 Nov 13;359(20):2121-34. doi: 10.1056/NEJMoa0708514. Erratum In: N Engl J Med. 2009 Sep 3;361(10):1027.
• Kohl S, Schonherr DM, Luigjes J, Denys D, Mueller UJ, Lenartz D, Visser-Vandewalle V, Kuhn J. Deep brain stimulation for treatment-refractory obsessive compulsive disorder: a systematic review. BMC Psychiatry. 2014 Aug 2;14:214. doi: 10.1186/s12888-014-0214-y.
• Eitan R, Shamir RR, Linetsky E, Rosenbluh O, Moshel S, Ben-Hur T, Bergman H, Israel Z. Asymmetric right/left encoding of emotions in the human subthalamic nucleus. Front Syst Neurosci. 2013 Oct 29;7:69. doi: 10.3389/fnsys.2013.00069. eCollection 2013.
• Mataix-Cols D, Fernandez de la Cruz L, Nordsletten AE, Lenhard F, Isomura K, Simpson HB. Towards an international expert consensus for defining treatment response, remission, recovery and relapse in obsessive-compulsive disorder. World Psychiatry. 2016 Feb;15(1):80-1. doi: 10.1002/wps.20299. No abstract available.
• Piallat B, Polosan M, Fraix V, Goetz L, David O, Fenoy A, Torres N, Quesada JL, Seigneuret E, Pollak P, Krack P, Bougerol T, Benabid AL, Chabardes S. Subthalamic neuronal firing in obsessive-compulsive disorder and Parkinson disease. Ann Neurol. 2011 May;69(5):793-802. doi: 10.1002/ana.22222. Epub 2010 Dec 28.
• Ooms P, Mantione M, Figee M, Schuurman PR, van den Munckhof P, Denys D. Deep brain stimulation for obsessive-compulsive disorders: long-term analysis of quality of life. J Neurol Neurosurg Psychiatry. 2014 Feb;85(2):153-8. doi: 10.1136/jnnp-2012-302550. Epub 2013 May 28.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: July 25, 2016
• First Posted (Estimated): July 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Quality of Life; Deep Brain Stimulation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Obsessive-Compulsive Disorder
• Other Study ID Numbers: 38RC15.344

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO