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

NCT ID: NCT02844049

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2027-04-30

Brief Summary

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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

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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.

Conditions

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Obsessive-Compulsive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Deep Brain Stimulation

DBS surgical procedure scheduled and realized

Group Type ACTIVE_COMPARATOR

Deep Brain Stimulation

Intervention Type DEVICE

surgical procedure

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Deep Brain Stimulation

surgical procedure

Intervention Type DEVICE

Other Intervention Names

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DBS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mircea Polosan, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU Henri Mondor

Créteil, , France

Site Status COMPLETED

University Hospital of Grenoble Michallon

Grenoble, , France

Site Status RECRUITING

Chu Nice - Hopital Pasteur

Nice, , France

Site Status RECRUITING

APHP La Pitié Salpêtrière

Paris, , France

Site Status RECRUITING

Ghu Sainte Anne

Paris, , France

Site Status RECRUITING

Universitätsklinikum Köln (AöR)

Cologne, , Germany

Site Status RECRUITING

Djurfeldt

Stockholm, , Sweden

Site Status RECRUITING

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Site Status RECRUITING

Countries

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France Germany Sweden Switzerland

Central Contacts

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Sandra David-tchouda, MD

Role: CONTACT

[email protected]
+33476767186

Sandrine Massicot, Master

Role: CONTACT

[email protected]
+33476768860

Facility Contacts

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Mircea POLOSAN, MD PhD

Role: primary

[email protected]
0033476765414

Denys FONTAINE, MD

Role: primary

[email protected]
04 92 03 84 50

Hélène BRUCKER

Role: backup

[email protected]
04 92 03 75 57

Bruno Millet, MD PhD

Role: primary

[email protected]
33142162894

Philippe DOMENECH, MD PhD

Role: primary

[email protected]

Djamila KORICHE

Role: backup

[email protected]
0145657665

Veerle VISSER-VANDEWALLE, MD

Role: primary

[email protected]
+49 221 478-82793

Diana DJURFELDT, MD PhD

Role: primary

[email protected]
+46 72 211 9562

Joao FLORES, MD

Role: primary

[email protected]

References

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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.

Reference Type BACKGROUND
PMID: 23580175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19005196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25085317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24194703 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26833615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21520240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23715912 (View on PubMed)

Other Identifiers

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38RC15.344

Identifier Type: -

Identifier Source: org_study_id