| CTRI Number |
CTRI/2018/06/014360 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
01/06/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Examining the efficacy of brain stimulation for a neuropsychiatric disorder called OCD |
|
Scientific Title of Study
|
Neurobiological correlates and translational implications of neuromodulation in OCD:
A high definition transcranial direct current stimulation (HD-tdcs) study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Janardhanan C Narayanaswamy |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry,
NIMHANS,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995837 |
| Fax |
|
| Email |
jairamnimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Janardhanan C Narayanaswamy |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry,
NIMHANS,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995837 |
| Fax |
|
| Email |
jairamnimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janardhanan C Narayanaswamy |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry,
NIMHANS,
Hosur road,
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995837 |
| Fax |
|
| Email |
jairamnimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Wellcome trust DBT India Alliance,
H.NO.8-2-684/3/K/19, First Floor
KAUSHIK SOCIEITY
ROAD NO 12
BANJARA HILLS
HYDERABAD 500034
Telangana
Phone No. 04040189445 |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health And Neurosciences NIMHANS Bangalore |
| Address |
The Director
NIMHANS
Bangalore
560029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Janardhanan C Narayanaswamy |
National Institute of Mental Health And Neurosciences , Bangalore |
Department of Psychiatry office, ground floor, Department of Psychiatry, National Institute of Mental Health And Neurosciences , Hosur road, Bangalore, 560029
Bangalore
KARNATAKA |
9481475125
jairamnimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee NIMHANS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers without psychiatric illness are recruited for the trial assessments (clinical scales, EEG, MRI, cognition) at the baseline. However, they will not receive any intervention. |
| Patients |
Patients with Obsessive Compulsive Disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active HD tDCS |
HD tDCS - a non-invasive brain stimulation technique will be used as active arm/ intervention arm.
Active HD tDCS will be offered to those participants who show less than 25% clinical improvement (based on YBOCS scale) and wish to take it after the randomisation phase (if they wish to) - i.e. open label extension for 10 more days of HD tDCS |
| Comparator Agent |
Sham HD tDCS |
HD tDCS sham mode will be used as a placebo comparator arm |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Diagnosis of OCD as per DSM-V criteria (American Psychiatric Association, 2013)
2. Age Range: 18 – 50 Years
3. Either Sex
4. Right-handedness
5. Stable psychotropic medications atleast for 12 weeks and not on cognitive behavioral therapy presently
6. Persistent symptoms despite adequate SSRI treatment (OCD symptom severity according to Yale Brown Obsessive Compulsive Scale score of atleast 16)
Healthy controls: Right handed;age,sex and education matched
|
|
| ExclusionCriteria |
| Details |
1. Comorbid psychosis, bipolar disorder, substance dependence (including nicotine dependence) features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation, aggression or excitement)
2. Any contraindication to HD-tDCS procedure-(i) metal in the head,(ii) implanted brain medical devices,(iii)local lesion or injury in the scalp / head
3. Co-morbid neurological/medical disease that can affect the brain structure/function |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Functional MRI (fMRI)- Resting fMRI and with cognitive activation task(Symptom provocation paradigm followed by Stop-signal task) |
Baseline and after 10 days of HD tDCS sessions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Magnetic resonance Spectroscopy – MRS for NAA and glutamate in-vivo signals at pre-SMA
Error Related Negativity (ERN)
Clinical assessments - illness severity ratings |
Baseline and after 10 days of HD tDCS sessions |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/06/2018 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Obsessive-compulsive disorder(OCD) is a common and
debilitating neuropsychiatric disorder. The proposed
research aims to examine the effect of anodal right pre-supplementary motor
area(pre-SMA) high definition transcranial direct current stimulation(HD-tDCS)
on neurocognitive functions, and respective physiological correlates in
patients with OCD who have persistent symptoms
despite being on adequate treatment with medications. Task-related
physiological alterations is proposed to be examined through comprehensive
assessment of neurohemodynamic and electrophysiological changes pertaining to the
key neurocognitive functions coupled with the assessment of neurochemical
alterations(glutamate and N-acetyl aspartate) in pre-SMA before and after 10 days of
HD-tDCS sessions (conducted 2 sessions per day) using a randomised sham controlled design. Following the RCT phase those patients who have only <25% improvement will be offered an open label extension phase for addition 10 days. The translational implication is to evaluate novel treatment options for OCD patients who do not respond to conventional treatment options and to understand the mechanistic basis for the brain stimulation method.
|