| CTRI Number |
CTRI/2025/12/098279 [Registered on: 02/12/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
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Public Title of Study
|
Effects of Brain Stimulation (tDCS) Combined with Cognitive Training on Executive Functioning of Children and Adolescents with ADHD |
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Scientific Title of Study
|
Effects of Transcranial Direct Current Stimulation (tDCS) Combined with a Developed Cognitive Training Module in Children and Adolescents with ADHD: A Randomized Controlled Trial
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| Trial Acronym |
NIL |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ananya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences (AlIMS), New Delhi |
| Address |
mECT facility, Department of Psychiatry, 2nd floor, AIIMS Emergency, All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi, India
New Delhi
DELHI
110029
India |
| Phone |
9140987973 |
| Fax |
|
| Email |
ananyagupta3327@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bichitra Nanda Patra |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences (AlIMS), New Delhi |
| Address |
Department of Psychiatry, All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9717880196 |
| Fax |
|
| Email |
patrabaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ananya Gupta |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Medical Sciences (AlIMS), New Delhi |
| Address |
mECT facility, second floor, AIIMS Emergency, All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9140987973 |
| Fax |
|
| Email |
ananyagupta3327@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, Technology Bhavan, New Mehrauli Road, New Delhi-110016, India |
|
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Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi – 110029 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ananya Gupta |
All India Institute of Medical Sciences, New Delhi |
mECT facility, second floor, AIIMS Emergency, All India Institute of Medical Sciences, Sri Aurobindo Marg, New Delhi
New Delhi
DELHI |
9140987973
ananyagupta3327@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, (2) ICD-10 Condition: F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type, (3) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, (4) ICD-10 Condition: F908||Attention-deficit hyperactivity disorder, other type, (5) ICD-10 Condition: F909||Attention-deficit hyperactivity disorder, unspecified type, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cognitive Training |
Digital problem-solving tasks targeting working memory, response inhibition and attention will be developed, with difficulty level increasing as the training progresses |
| Comparator Agent |
Sham cognitive training |
task with similar design, sounds, colours, and feedback like the active cognitive training module will be provided, which does not actively train the targeted executive functions |
| Comparator Agent |
Sham tDCS |
1 mA current will be delivered only during the ramp up and ramp down period of 30 seconds each |
| Intervention |
Transcranial Direct Current Stimulation |
tDCS will be delivered using a Starstim 32 (Neuroelectrics, GmBH) machine, with anode over left dorsolateral prefrontal cortex (dlPFC) and cathode over right dlPFC for 20 minutes, with ramp-up and ramp-down period of 30 seconds each. The current intensity will be 1 mA and one session each day for 5 days will be given. Total duration of stimulation is 100 minutes (20 minutes a day/session) |
|
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Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Clinical diagnosis of ADHD as per DSM-5
IQ greater than or equal to 80
Availability of at least one parent as an informant
Ability to comprehend instructions and cooperate for intervention
Ability to read and understand English and/or Hindi
|
|
| ExclusionCriteria |
| Details |
Metal implants or skin lesions near electrode site
History of epilepsy, seizures, or other known organic neurological disorders
Patients with autism, psychosis or bipolar disorder
Uncooperative patient/ parent
Has not been a part of any interventional trial in previous 3 months
Drug-naive or drug-free for at least 48 hours
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Working Memory, Response Inhibition and Attention |
Pre and Post Assessment (after 5 sessions) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the spectral values and Oxygenated and Deoxygenated Haemoglobin Concentrations in the dlPFC.
|
Pre and Post Assessment (after 5 sessions)
|
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
01/01/2026 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Aim for Phase 1: To develop and validate a digital cognitive training (CT) module targeting working memory, response inhibition and attention.
H1: The cognitive training module will lead to significant changes in the participants’ working memory, response inhibition and attention.
H2: The developed cognitive training module will be rated as acceptable and user-friendly by the participants.
Aim for Phase 2: To investigate the effects of transcranial direct current stimulation (tDCS) with and without cognitive training on working memory, response inhibition and attention in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
H1: There will be a significant difference in working memory, response inhibition and attention following tDCS.
H2: There will be a significant difference in cognitive outcomes between the group receiving tDCS combined with cognitive training and the groups receiving tDCS alone or cognitive training alone.
H3: There will be significant differences in neurophysiological markers (spectral values, HbO, and HbR) among the three groups: tDCS with cognitive training, tDCS alone, and sham tDCS with cognitive training.
A gamified cognitive training module will be developed using JAVA. The module will be validated on five children and adolescents with ADHD. For phase 2, participants will be recruited from the Psychiatry OPD of AIIMS and will be screened for IQ using MISIC. Baseline assessment will be done, followed by allocation of participants into one of the three groups in the study, with an allocation ratio of 1:1:1. After five days of intervention, post-assessment will be conducted. Participants who comply with extra sessions will undergo five more sessions. Participants will be thanked for their participation.
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