Deep brain stimulation for severe obsessive compulsive disorder

ISRCTN	ISRCTN18430630
DOI	https://doi.org/10.1186/ISRCTN18430630
Secondary identifying numbers	13158

Submission date: 22/04/2015
Registration date: 22/04/2015
Last edited: 31/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Himanshu Tyagi
Scientific

UCL Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Deep brain stimulation for severe obsessive compulsive disorder: efficacy and mechanisms of ventral striatum and subthalamic nucleus targets
Study hypothesis	The overarching aim is to compare the effects of VC/VS and STN DBS in the same patients. This study will test the hypothesis, grounded in cognitive neuroscience, that DBS at both sites is better than either site alone for treating the symptom dimensions of OCD. Specifically, this study will employ novel cognitive paradigms and neurophysiological measures of cortical synaptic function to test the hypothesis that VS/VC and STN DBS have different mechanisms of action and that alleviation of OCD symptoms is mediated by improvement in mood/anxiety with VS/VC DBS and by directly interrupting obsessions and compulsions with STN DBS. This study will additionally determine whether adjunctive CBT enhances the response to DBS by providing the cognitive and behavioural skills to optimise symptom management and daily function.
Ethics approval(s)	ref: 12/LO/1087
Condition	Topic: Mental Health; Subtopic: Personality disorder; Disease: Personality disorders
Intervention	1. Cognitive Behavioural Therapy: CBT for OCD including Graded Exposure and Self Imposed Response Prevention 2. Deep Brain Stimulation: A neurosurgical procedure involving the implantation of a medical device in brain Study Entry : Single Randomisation only
Intervention type	Mixed
Primary outcome measure	YBOCS improvement greater than or equal to 35%; Timepoint(s): 15 months
Secondary outcome measures	N/A
Overall study start date	22/01/2013
Overall study end date	31/08/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 6; UK Sample Size: 6
Total final enrolment	6
Participant inclusion criteria	The inclusion criteria have been designed to be consistent with previous OCD DBS studies and to ensure that patients have not responded in a useful and sustained manner to either modifications of medication or any form of CBT 1. Patients must have undergone intensive treatment and have demonstrable treatment resistance as defined by: 1.1. At least two SRIs for a minimum of 12 weeks at optimal British National Formulary (BNF) doses 1.2.Augmentation of SRI treatment with antipsychotic drugs administered at maximally tolerated doses or by extending the SSRI dose beyond BNF limits 1.3. Two trials of CBT of at least 10 hours 1.4. Failed inpatient treatment 2. Patients must also satisfy the following criteria: 2.1. Age > 20 years 2.2. Confirmation of a primary diagnosis of obsessive compulsive disorder (ICD10 F42.0—F42.9) 2.3. Duration of illness of at least 10 years 2.4. At least 2 years of unremitting symptoms despite intensive psychopharmacological and psychological treatment or failure to sustain, over a 3 month period, a response to inpatient psychological treatment by at least 33% with accompanying optimised pharmacological therapy 2.5. A minimum score of 32 on Yale Brown Obsessive Compulsive Scale (YBOCS 22) thus constituting profound illness and a maximum score of 50 on the DSM IV General Assessment of Function Scale (GAF) 2.6. Ability to provide sustained informed consent
Participant exclusion criteria	1. Current diagnoses of substance misuse (ICD10 F10—F19), organic brain syndrome (ICD10 F00—F09), adult personality disorder (ICD10 F60—F69), pervasive developmental disorder (ICD10 F84); schizophrenia (ICD10 F20-F29) and bipolar disorder (ICD 10 F30-31) 2. Contraindications to neurosurgery 3. Pregnancy
Recruitment start date	22/01/2013
Recruitment end date	31/08/2015

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UCL Institute of Neurology

Queen Square
London
WC1N 3BG
United Kingdom

Sponsor information

University College London
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Government

Medical Research Council (Grant Codes: MR/J012009/1)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2019	31/03/2020	Yes	No

Editorial Notes

31/03/2020: Publication reference added.
14/09/2017: No publications found, verifying study status with principal investigator.