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

NCT02844049 | Recruiting DMC

• 1 other identifier: 38RC15.344
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 8

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.

Conditions

Obsessive-Compulsive Disorder

Keywords

Deep Brain Stimulation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (22)

• Psychiatric assessment n°1

  1 year

• Psychiatric assessment n°2

  1 year

• Psychiatric assessment n°3

  1 year

• Psychiatric assessment n°4

  1 year

• Psychiatric assessment n°5

  1 year

Study Arms (2)

Deep Brain Stimulation

ACTIVE COMPARATOR

DBS surgical procedure scheduled and realized

Device: Deep Brain Stimulation

Control group

NO INTERVENTION

medical treatment (psycho- and pharmaco-therapy) will continue to be given and optimized according to the defined BMT strategies and criteria

Interventions

Deep Brain Stimulation DEVICE

surgical procedure

Also known as: DBS

Deep Brain Stimulation

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OCD for \> 5 years
• YBOCS\> 25 and/or YBOCS sub-scale \>15
• GAF\< 45
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (8)

CHU Henri Mondor

Créteil, France

COMPLETED

University Hospital of Grenoble Michallon

Grenoble, France

RECRUITING

Chu Nice - Hopital Pasteur

Nice, France

RECRUITING

APHP La Pitié Salpêtrière

Paris, France

RECRUITING

Ghu Sainte Anne

Paris, France

RECRUITING

Universitätsklinikum Köln (AöR)

Cologne, Germany

RECRUITING

Djurfeldt

Stockholm, Sweden

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, Switzerland

RECRUITING

Related Publications (7)

• 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.

  PMID: 23580175 BACKGROUND

• 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.

  PMID: 19005196 BACKGROUND

• 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.

  PMID: 25085317 BACKGROUND

• 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.

  PMID: 24194703 BACKGROUND

• 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.

  PMID: 26833615 BACKGROUND

• 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.

  PMID: 21520240 BACKGROUND

• 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.

  PMID: 23715912 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Study Officials

• Mircea Polosan, MD PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra David-tchouda, MD

CONTACT

+33476767186; SDavidTchouda@chugrenoble.fr

Sandrine Massicot, Master

CONTACT

+33476768860; smassicot@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: July 26, 2016
• Study Start: September 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); FR (5); DE (1); CH (1)