CTRI Number |
CTRI/2023/03/050546 [Registered on: 10/03/2023] Trial Registered Prospectively |
Last Modified On: |
04/06/2023 |
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
|
Use of brain stimulation for treatment of Depression |
Scientific Title of Study
|
A randomized controlled trial of the effectiveness of Transcranial Direct Current Stimulation (tDCS) for Treatment of Major Depression |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Rohit Verma |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room No. 4096, 4th Floor, Teaching Block AIIMS, Ansari Nagar South DELHI 110029 India |
Phone |
09868005491 |
Fax |
|
Email |
rohit.aiims@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Rohit Verma |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room No. 4096, 4th Floor, Teaching Block AIIMS, Ansari Nagar
DELHI 110029 India |
Phone |
09868005491 |
Fax |
|
Email |
rohit.aiims@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Rohit Verma |
Designation |
Additional Professor |
Affiliation |
All India Institute of Medical Sciences |
Address |
Room No. 4096, 4th Floor, Teaching Block AIIMS, Ansari Nagar
DELHI 110029 India |
Phone |
09868005491 |
Fax |
|
Email |
rohit.aiims@gmail.com |
|
Source of Monetary or Material Support
|
All India Institute of Medical Sciences New Delhi |
|
Primary Sponsor
|
Name |
All India Institute of Medical Sciences New Delhi |
Address |
Ansari Nagar New Delhi |
Type of Sponsor |
Government medical college |
|
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 Rohit Verma |
All India Institute of Medical Sciences New Delhi |
Room No. 4096, 4th Floor, Teaching Block Department of Psychiatry, AIIMS, Ansari Nagar New Delhi South DELHI |
09868005491
rohit.aiims@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institute Ethics Committee AIIMS New Delhi |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Active Transcranial Direct Current Stimulation (tDCS) |
The participants will receive stimulation current at 2mA for 20 min with ramp up of 30 sec and ramp down of 30 sec in a single session. Two sessions per day will be given to the participants. Twenty sessions will be given to a single participant. The anode will be positioned at F3 and cathodal returns will be placed in a ring around the anode (FC1, AF3, F7, FC5) utilizing the International 10-20 EEG system. |
Comparator Agent |
Sham Transcranial Direct Current Stimulation (tDCS) |
The sham group participants will be receiving the similar set up as the active group participants {viz. anode will be positioned at F3 and cathodal returns will be placed in a ring around the anode (FC1, AF3, F7, FC5)} with the only change that the tDCS system will operate in sham mode delivering no current except during the ramp up and down phases of 30 sec each so that the participant remain blind to the stimulation delivery |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
1. Between age 18-55 years
2. Either gender
3. Right-handed individuals
4. Patients fulfilling the Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM 5) criteria for the diagnosis of MDD
5. Ability to read Hindi or English language
6. Willing to give informed consent
7. Medication naïve or Treatment free from prior 2 weeks or on a stable standard antidepressant regimen {including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclic (TCAs)} with no change in treatment 4-weeks prior to tDCS intervention
8. HAMD score ≥ 24 (severe depression)(Chistyakov et al., 2010; Goodman et al., 2006) |
|
ExclusionCriteria |
Details |
1. Chronic medical or neurological illness (previously diagnosed)
2. Lifetime substance use disorder (excluding tobacco or caffeine) (as per DSM-5)
3. Suffering from or any psychiatric illness other than MDD
4. Not cooperative for testing
5. Past history of significant head injury
6. Known case of intellectual disability
7. Known or suspected pregnancy or currently lactating
8. Head metal implants
9. Subjects with significant suicidal risk upon clinical assessment
10. Any history of seizure
11. Previous history of receiving any brain surgical procedures
12. Implanted metal in their body
13. Electrical or magnetic stimulation on brain in the previous three months |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Inter-group differences in change in scale scores (HAMD-17, MADRS and CGI). |
At baseline before beginning tDCS session and then after 10 and 20 sessions as well as after 4 weeks of last tDCS session |
|
Secondary Outcome
|
Outcome |
TimePoints |
Change in parameters obtained in EEG, fNIRS and MRI for correlation to symptom improvement |
At baseline before beginning tDCS session and then after 20 sessions and after 24 weeks of last tDCS session |
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
01/04/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
Study not yet done or published |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Major depressive disorder (MDD) is a deliberating mental
disorder with a high prevalence, and it produces heavy burden and suicide. It
is one of the most common psychiatric disorders, but pharmacological
treatments are ineffective in a substantial fraction of patients and are
accompanied by unwanted and very serious side effects. Therefore, in
addition to antidepressants treating MDD, non-pharmacological interventions
have been proposed to treat MDD.
Personalized interventions for people suffering from psychiatric
conditions at all stages of illness have seen an evolution in the past few
years, from genomic-based subtyping and imaging-based subtyping for the
optimization of first-line treatment selection to new methods for
individualized image-guided targeting in patients via invasive brain
stimulation or non-invasive brain stimulation. Recent literature provides
exciting new proof-of-concept strategies for the correction of patient-specific
dysfunctions in emotional–cognitive brain circuits for depression by
non-invasive neuromodulation strategies like transcranial direct current
stimulation (tDCS). Transcranial Direct Current stimulation (tDCS) has been
shown to be an effective treatment for depression that can be made portable and
used safely, in the privacy of people homes. It could act as the first line of
defense treatment for depression. In this study, we seek further validation on
the efficacy of tDCS for depression.
This proof-of-concept study intends to recruit 20
individuals suffering from MDD fulfilling the inclusion and exclusion criterion
randomly dividing them to receive either active or sham tDCS. 10 patients would
be recruited for active tDCS arm and 10 will be included in sham tDCS arm.
The outcome parameters would be standard questionnaire-based evaluation method
for depression - Montgomery and Asberg Depression Rating Scale
(MADRS), Hamilton Depression Rating Scale (HDRS-17) and Clinical Global
Impressions (CGI) scale. In addition, electroencephalography (EEG) and
functional near infra-red spectroscopy (fNIRS) and Magnetic resonance imaging
(MRI) based markers will also be evaluated to analyze if there could be any
putative quantitative biomarker for treatment related progress in
depression. Depression questionnaires and cognitive batteries will be
performed before the 1st session, after the 10th session and after the 20th
session of tDCS as well as 4 weeks after the last tDCS session. Sessions will
be conducted twice daily over 10 working days. Stimulation will begin for
20 min in a single session, two sessions in a day separated by an inter-session
interval of at least 3 hours. Participants in active group will receive stimulation
during the entire 20 min session while those in sham group will receive
stimulation only during the ramp up and ramp down period of about 30 sec so
that the participant remain blind to the stimulation delivery. The brain
imaging (fNIRS, qEEG & MRI) will be done at baseline before beginning the
first tDCS session, repeated after completion of last tDCS session and after 24
weeks (about 6 months) of last tDCS session. Pre- and post-stimulation session
EEG will be recorded at resting state daily, and for select event related
potential (ERP) before the 1st session, and after the 20th session of
tDCS. Analysis will be done using SPSS with p value significant at 0.05. |