| CTRI Number |
CTRI/2020/03/024131 [Registered on: 20/03/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Identifying factors that help predict improvement with deep brain stimulation (a surgical treatment) for obsessive-compulsive disorder |
|
Scientific Title of Study
|
Identification of biomarkers that predict response to deep brain stimulation over
subthalamic nucleus in obsessive-compulsive disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shyam Sundar Arumugham |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neuro Sciences (NIMHANS) |
| Address |
Department of Psychiatry, NIMHANS
Hosur Road
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
9008600112 |
| Fax |
|
| Email |
a.shyamsundar@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Wellcome Trust DBT India Alliance 8-2-684/3/K/19 1st Floor Kaushik Society Banjara Hills Hyderabad 500034 |
|
|
Primary Sponsor
|
| Name |
Wellcome Trust DBT India Alliance |
| Address |
8-2-684/3/K/19 1st Floor Kaushik Society Banjara Hills Hyderabad 500034 |
| Type of Sponsor |
Other [Funding agency government private partnership] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shyam Sundar Arumugham |
National Institute of Mental Health and Neuro Sciences |
Hosur Road
Bengaluru
Bangalore
KARNATAKA |
9008600112
a.shyamsundar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F422||Mixed obsessional thoughts and acts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Deep brain stimulation |
Intracranial electrodes attached to a stimulator to stimulate the subthalamic nucleus in the brain. The treatment involves a one-time surgical implantation of the electrodes in the brain, following which continuous stimulation would be provided through an implanted battery throughout the study period. The stimulation is an add-on treatment along with other standard pharmacological and non-pharmacological treatments as decided by the treating psychiatrist. |
| Comparator Agent |
Treatment as usual |
Standard medical and psychotherapeutic intervention. Standard pharmacological and non-pharmacological treatments would be provided as decided by the treating psychiatrist |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i. Age between 18 to 60 years.
ii. Primary diagnosis of obsessive-compulsive disorder satisfying the DSM-5 criteria2 , established using Mini International Neuropsychiatric Interview-7.0.2. .
iii. Duration of OCD  5 years.
iv. Yale-Brown Obsessive Compulsive Scale (YBOCS) score of  28 or  14 if the subject has either predominantly obsessions or compulsions alone.
v. Clinical Global Impressions – Severity (CGI-S) scale of  5
vi. Disability of  40% as evaluated by Indian Disability Evaluation and Assessment Scale (IDEAS).
vii. Failure to obtain meaningful improvement in OCD despite adequate trial with standard treatment strategies which should include:
a. At least 3 trials of serotonin reuptake inhibitors (SRIs), one of which should be clomipramine, which were either ineffective or poorly tolerated. An adequate trial includes recommended dose of SRIs for  12 weeks duration each46.
b. Augmentation of SRIs with at least 2 agents for  6 weeks, one of which should be either risperidone or aripiprazole.
c. Trial of structured behaviour therapy/cognitive behaviour therapy for at least 20 sessions or demonstrated inability to tolerate the anxiety due to therapy.
|
|
| ExclusionCriteria |
| Details |
i. Diagnosis of bipolar disorder, psychotic disorder of ³ 3 months duration as assessed
with MINI-7.0.2
ii. Current substance use disorder (except caffeine or nicotine use disorder) or Major
depressive episode or current high suicidality, as assessed with MINI-7.0.2.
iii. Severe personality disorder as assessed with Structured Clinical Assessment of
DSM-5-PD version
iv. Clinically significant abnormality on magnetic resonance imaging (MRI) of the brain.
v. Pregnancy, contraindication for DBS/anaesthesia/preoperative MRI, inability to
comply with surgical requirements. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yale Brown Obsessive Compulsive severity scale (Y-BOCS) |
Yale Brown Obsessive Compulsive severity scale (Y-BOCS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Global Impressions-severity, Hamilton depression rating scale, Hamilton anxiety rating scale, WHO-Quality of life -BREF, WHO-Disability Assessment Schedule |
12 months post-surgery, assessment conducted every 1 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Key goals & hypotheses: The current proposal aims to identify biomarkers that predict treatment response to deep brain stimulation (DBS) over subthalamic nucleus (STN) in subjects with chronic and refractory obsessive-compulsive disorder (OCD). We hypothesize that baseline STN-prefrontal connectivity, low frequency oscillatory activity over frontal lobes/STN and impaired performance on response inhibition/response conflict tasks would predict improvement in OCD. Rationale: STN is a component of cortico-striato-thalamo-cortical circuit implicated in OCD. Electrophysiological activity and neural connectivity of STN contribute to OCD relevant neurocognitive functioning, such as response inhibition and conflict monitoring. DBS may improve OCD by modulating STN connectivity and electrophysiological activity mediated by the effects on neurocognitive functioning. Study design: We plan to perform DBS over STN in 24 subjects with treatment-refractory OCD. Structural/functional imaging, electrophysiological recording and neurocognitive assessment would be performed at baseline. The subjects would undergo structured clinical assessment for 12 months post-surgery. A group of 24 healthy volunteers and 24 subjects with treatment-refractory OCD who do not undergo surgery would be recruited as comparison subjects for comparing the biomarkers. Baseline biomarkers would be tested as predictors for clinical response. Neuroadaptive changes would be studied through reassessment of neurocognitive functioning and electroencephalographic activity post-DBS. Impact: Identification of predictors would help in patient selection and understand the mechanism of action of this invasive and expensive treatment, paving way for innovations such as closed loop stimulation. |