| CTRI Number |
CTRI/2025/10/095996 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
How Brain Training Helps Middle School Girls Think, Feel, and Learn Better |
|
Scientific Title of Study
|
Impact of Brain Training on Cognitive Skills, Emotional Well-Being, and Academic Performance: A Comparative Analysis Among Middle School Girls. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PK/CT/007/25, Version No.: 01, dated 25-Jul-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Jeph |
| Designation |
Counseling Psychologist |
| Affiliation |
PhysioKarma Solutions Pvt. Ltd. |
| Address |
Physio Karma Solutions Pvt. Ltd., No. 8, Village Dheerpur, Nirankari Colony, Psycholohy Department.
New Delhi
DELHI
110009
India |
| Phone |
8447454806 |
| Fax |
|
| Email |
akankshajeph03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gokulkrishnan R |
| Designation |
Sports Psychologist |
| Affiliation |
PhysioKarma Solutions Pvt. Ltd. |
| Address |
Physio Karma Solutions Pvt. Ltd., No. 8, Village Dheerpur, Nirankari Colony, Sports Psychology Department.
New Delhi
DELHI
110009
India |
| Phone |
6382179892 |
| Fax |
|
| Email |
rjgokul61100@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gokulkrishnan R |
| Designation |
Sports Psychologist |
| Affiliation |
PhysioKarma Solutions Pvt. Ltd. |
| Address |
Physio Karma Solutions Pvt. Ltd., No. 8, Village Dheerpur, Nirankari Colony, Sports Psychology Department.
New Delhi
DELHI
110009
India |
| Phone |
6382179892 |
| Fax |
|
| Email |
rjgokul61100@gmail.com |
|
|
Source of Monetary or Material Support
|
| Physio Karma Solutions Pvt. Ltd., No. 8, Village Dheerpur, Nirankari Colony, Delhi 110009 |
|
|
Primary Sponsor
|
| Name |
Gaurav Sharma |
| Address |
House No. 8, Village Dheerpur, Nirankari Colony, Delhi 110009 |
| Type of Sponsor |
Other [Gaurav Sharma is the Director of the Organization Physio Karma Solutions Pvt. Ltd.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akanksha Jeph |
B. M. Gange Girls Senior Secondary School |
Brain Training Lab inside the school, 21, Raj Niwas Marg, Ludlow Castle, Civil Lines
New Delhi
DELHI |
8447454806
akankshajeph03@gmail.com |
| Dr Akanksha Jeph |
Francis Girls Senior Secondary School |
Brain Training Lab inside the school, 17, Kalidas Road, Daryaganj
New Delhi
DELHI |
8447454806
akankshajeph03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Good Society For Ethical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No Condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Structured Brain Training |
The structured brain training will include these three cognitive training modalities focusing in improving attention, memory, spatial awareness, and emotional well-being:
1. Mendi Neurofeedback Headset Training
2. Memorie Cognitive Training Games
3. Neurotrackerx Multiple Object Tracking
These are mobile and laptop based games designed to target cognitive domains and improve them. The participants will be taking 2 to 3 sessions in a week with every session lasting 30 minutes till the end of the intervention period. Trained psychology professionals will be conducting these sessions and ensure safety of the participants. |
| Comparator Agent |
Structured Brain Training |
The structured brain training will include these three cognitive training modalities focusing in improving attention, memory, spatial awareness, and emotional well-being: 1. Mendi Neurofeedback Headset Training 2. Memorie Cognitive Training Games 3. Neurotrackerx Multiple Object Tracking These are mobile and laptop based games designed to target cognitive domains and improve them. The participants will be taking 2 to 3 sessions in a week with every session lasting 30 minutes till the end of the intervention period. Trained psychology professionals will be conducting these sessions and ensure safety of the participants. |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Female middle school students residing in Delhi. The participants must be aged between 11 and 15 years. The participants must not be physically or mentally challenged. The participants must be enrolled in middle school. |
|
| ExclusionCriteria |
| Details |
Male participants, physically and mentally challenged participants, and participants who are below 11 years of age and above 15 years of age. participants who are not currently enrolled in middle school. Participants outside of Delhi. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Attention- Measured by Concentraition grid
2. Memory- Measured by Digit Span Test
3. Emotional Intelligence- Measured by The Schutte Self-Report Emotional Intelligence Test
4. Stress- Measured by Perceived Stress Scale
5. Mood- Measured by Profile of Mood States
6. Academic Scores- Recent Term Academic Scores
|
We will measure all these variables at the start of the study before the intervention phase. After the intervention we will measure these variables again to see the outcome.
For phase one of the study, we will measure the outcome after 3 months of intervention. And for the second phase of the study, we will measure the outcome after 6 months of intervention phase. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="1000"
Sample Size from India="1000"
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)
|
16/11/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objectives: This study aims to examine whether structured brain training improves concentration, memory retention, stress, emotional intelligence, mood states and academic performance in middle school girls aged 11-15 years.
Methods: This is an experimental, quantitative study involving two phases, where the first phase involves screening 500 participants and conducting the intervention for 3 months, and the second phase of the study will also screen 500 students and the intervention will go on for 6 months. Eligible sparticipants will be randomly divided into experimental and control groups in each phase. The experimental group will undergo brain training sessions 2-3 times weekly. Key assessment tools include the Concentration Grid Test, Perceived Stress Scale, Digit Span Test, The Schutte Self-Report Emotional Intelligence Test, Profile of Mood States, and Academic records. The data will be analysed using SPSS v23 with paired and independent t-test.
Primary Hypotheses: 1. Attention Span H1: There will be a significant difference in attention span between the control group and the experimental group. 2. Stress Levels H2: There will be a significant difference in stress levels between the control group and the experimental group. 3. Memory / Retention H3: There will be a significant difference in memory/retention between the control group and the experimental group. 4. Emotional Intelligence H4: There will be a significant difference in emotional intelligence between the control group and the experimental group. 5. Mood States H5: There will be a significant difference in mood states between the control group and the experimental group. 6. Academic Performance H6: There will be a significant difference in academic performance between the control group and the experimental group.
Expected Outcome: We anticipate significant cognitive, emotional and academic improvements in the experimental group validating structured brain training as an effective school based mental health and academic performance enhancement tool. |