| CTRI Number |
CTRI/2018/04/013413 [Registered on: 23/04/2018] Trial Registered Prospectively |
| Last Modified On: |
13/04/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of High- Definition Transcranial Direct Current Stimulation on Cognitive Deficits in Schizophrenia |
|
Scientific Title of Study
|
Neurobiological Correlates of the Effect of Add-On HD-tDCS for Working Memory Deficit in Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sowmya S |
| Designation |
PhD Scholar and Research training Fellow |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
National Institute of Mental Health And Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995366 |
| Fax |
|
| Email |
sowmya.nimhans@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sowmya S |
| Designation |
PhD Scholar and Research training Fellow |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
National Institute of Mental Health And Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995366 |
| Fax |
|
| Email |
sowmya.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sowmya S |
| Designation |
PhD Scholar and Research training Fellow |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Psychiatry
National Institute of Mental Health And Neurosciences, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
08026995366 |
| Fax |
|
| Email |
sowmya.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Wellcome Trust/DBT India Alliance
H. No. 8-2-684/3/K/19, 1st Floor, Kaushik Society
Road No. 12, Banjara Hills, Hyderabad - 500034 |
|
|
Primary Sponsor
|
| Name |
Dr Sowmya S |
| Address |
Department of Psychiatry
National Institute of Mental Health And Neurosciences, Bangalore- 560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sowmya S |
National Institute of Mental Health And Neurosciences, Bangalore |
Translational Psychiatry Lab,
Neurobiology Research Center,
Department of Psychiatry,
National Institute of Mental Health And Neurosciences
Bangalore
Bangalore
KARNATAKA |
9945171983
sowmya.nimhans@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, National Institute of Mental Health And Neurosciences, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sham - High Definition trans-cranial Direct Current Stimulation(HD-tDCS) |
Sham - High Definition trans-cranial Direct Current Stimulation(HD-tDCS) |
| Intervention |
True - High Definition trans-cranial Direct Current Stimulation(HD-tDCS) |
It is a non invasive neuromodulatory brain stimulation technique that delivers low intensity direct current, using scalp based electrodes facilitating or inhibiting spontaneous neuronal activity. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Schizophrenia and related disorders as per DSM criteria(Diagnostic and Statistical Manual for Mental Disorders, American Psychiatric Association), Right-handed, Lack of clinically significant positive symptoms as per established criteria and patient being on stable medications, Minimum education upto 8th standard, having significant cognitive deficits according to predefined criteria, Written informed consent obtained. |
|
| ExclusionCriteria |
| Details |
Any contraindication to tDCS procedure (for example, metal in the head, implanted brain medical devices, local lesion or injury in the scalp/head), Co-morbid substance dependence (except tobacco and caffeine), Co-morbid neurological disease, Left/Mixed Handedness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Severity of Working memory deficits.
2. Change in the neural correlates involved in Working memory deficits(Using brain imaging techniques like, structural MRI,resting fMRI, task based fMRI) |
Twice. First time (Day 1), before the treatment
with HD-tDCS is given. And second time on the last day(day 5), after the completion of 10 session of HD-tDCS treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in the neural correlates involved in Working memory deficits(Using brain imaging techniques like, structural MRI,resting fMRI, task based fMRI) |
Twice. First time (Day 1), before the treatment
with HD-tDCS is given. And second time on the last day(day 5), after the completion of 10 session of HD-tDCS treatment. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
23/04/2018 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No publications yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Schizophrenia, in addition to the positive and negative symptoms, is associated with impairments in cognitive functioning. Working memory (WM) is one of the cardinal deficits related to certain core symptoms of schizophrenia. WM impairment is a major predictor of functional outcome and quality of life in schizophrenia; WM deficits are not generally responsive to standard antipsychotic treatment. Transcranial direct current stimulation (tDCS) is a novel non-invasive focal brain stimulation technique using a low intensity direct current between two electrodes placed over the scalp. tDCS adaptively modulates neuroplasticity; this is partly dependent on BDNF regulation as well as genetic variation (val66met). Contextually, impaired BDNF function underlies WM deficits in schizophrenia. Very recently, an optimized version of tDCS, namely – High- Definition tDCS (HD-tDCS), has been proposed and studies have demonstrated superiority of this technique in terms of focalized neuromodulation as well as longer lasting adaptive plasticity effects. In this background, the current study, a randomized double blinded, placebo controlled trial will explore the neurobiological correlates of the effect of Add-On HD-tDCS for WM Deficits in Schizophrenia with the following objectives: a) To evaluate the neurobiological correlates of the effect of add-on HD-tDCS in patients with schizophrenia with deficient working memory ; b) To examine the neurobiological correlates (functional MRI activation as well as BDNF gene variation and expression) of WM deficit in schizophrenia. The potential translational implications of the study include: Understanding neurobiology of WM deficits in schizophrenia; Novel neurobiological correlates of clinical response to HD-tDCS in patients with schizophrenia with WM deficits; Development of personalized neuromodulation for treating schizophrenia in future.
|