Deep brain stimulation for severe obsessive compulsive disorder
| ISRCTN | ISRCTN18430630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18430630 |
| Protocol serial number | 13158 |
| Sponsor | University College London |
| Funder | Medical Research Council (Grant Codes: MR/J012009/1) |
- 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 of protocol
Not provided at time of registration
Contact information
Dr Himanshu Tyagi
Scientific
Scientific
UCL Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Deep brain stimulation for severe obsessive compulsive disorder: efficacy and mechanisms of ventral striatum and subthalamic nucleus targets |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
YBOCS improvement greater than or equal to 35%; Timepoint(s): 15 months |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 31/08/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 6 |
| Total final enrolment | 6 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/01/2013 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UCL Institute of Neurology
Queen Square
London
WC1N 3BG
United Kingdom
London
WC1N 3BG
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/03/2020: Publication reference added.
14/09/2017: No publications found, verifying study status with principal investigator.
