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

Obsessive-Compulsive Disorder Clinical Trial

— EQOLOC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02844049
• Other study ID #: 38RC15.344
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: University Hospital, Grenoble
• Contact: Sandra David-tchouda, MD
• Phone: +33476767186
• Email: SDavidTchouda[@]chugrenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2027
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Obsessive-Compulsive Disorder

Intervention

Device:
• Deep Brain Stimulation
surgical procedure

Locations

Country	Name	City	State
France	CHU Henri Mondor	Creteil
France	University Hospital of Grenoble Michallon	Grenoble
France	Chu Nice - Hopital Pasteur	Nice
France	APHP La Pitié Salpêtrière	Paris
France	Ghu Sainte Anne	Paris
Germany	Universitätsklinikum Köln (AöR)	Koln
Sweden	Djurfeldt	Stockholm
Switzerland	Hôpitaux Universitaires de Genève	Geneve

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Countries where clinical trial is conducted

France,  Germany,  Sweden,  Switzerland, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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