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CTRI Number  CTRI/2025/09/095029 [Registered on: 18/09/2025] Trial Registered Prospectively
Last Modified On: 18/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Occupational Therapy ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Usefulness of an App based intervention to improve cognitive capacities in Adult patients with Brain tumors: An Experimental Study 
Scientific Title of Study   Effectiveness of an App based Cognitive Intervention Program for Cognitive Rehabilitation Training in Adult Patients with Brain Tumors in a Tertiary Care Setting: A Pilot Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jagmohan Lal Meena 
Designation  Associate Professor and Scientific Assistant D 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  Department of Occupational Therapy RRU Building Room 107 ACTREC TATA MEMORIAL CENTRE NAVI MUMBAI

Raigarh
MAHARASHTRA
410210
India 
Phone  9167170518  
Fax    
Email  jlm_therapist@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Jagmohan Lal Meena 
Designation  Associate Professor and Scientific Assistant D 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  Department of Occupational Therapy RRU Building Room 107 ACTREC TATA MEMORIAL CENTRE NAVI MUMBAI

Raigarh
MAHARASHTRA
410210
India 
Phone  9167170518  
Fax    
Email  jlm_therapist@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Jagmohan Lal Meena 
Designation  Associate Professor and Scientific Assistant D 
Affiliation  Advanced Centre for Treatment Research and Education in Cancer  
Address  Department of Occupational Therapy RRU Building Room 107 ACTREC TATA MEMORIAL CENTRE NAVI MUMBAI

Raigarh
MAHARASHTRA
410210
India 
Phone  9167170518  
Fax    
Email  jlm_therapist@yahoo.co.in  
 
Source of Monetary or Material Support  
Advanced Centre for Treatment Research and Education in Cancer Tata Memorial Centre  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jagmohan Lal Meena  Advanced Centre for Treatment Research and Education in Cancer   Department of Occupational Therapy RRU Building Room 107 ACTREC TATA MEMORIAL CENTRE NAVI MUMBAI
Raigarh
MAHARASHTRA 		 09167170518
09167170518
jlm_therapist@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMC- Institutional Ethics Committee-III  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  The Control group will receive Non-Computerized Interventions for a duration of 45 minutes/session, 3 sessions/week for 12 weeks which will include 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece non-computerized picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining.  
Intervention  Experimental Group  The Experimental Group will receive intervention for a duration of 45 + 30 minutes which will include Cognitive Interventions through Non-Computerized Intervention 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining. In addition, the experimental group will receive a 12-week cognitive intervention training program will involve the use of Cognifit which consists of cognitive facilitation games which are directed at Attention, Memory, Processing Speed and Executive Functions administered over three sessions per week where each session is of 30-minute duration.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  This study will include Patient Participants with benign or malignant primary brain tumor who are of age above 18 years with a MoCA score between 10 -25 (Mild & Moderate Cognitive Impairment). Patients who have completed Radiation Therapy will be taken. Participants should be able to read and understand Basic English Language and should be of ECOG status 0,1 or 2 
 
ExclusionCriteria 
Details  Exclusion Criteria:
This study will exclude participants of age less than 18 with metastatic Brain Tumor or presence of any psychiatric illness. Patients with MoCA score 26 or above 26 will not be included. Severe Cognitive Impairment will not be included. Poor general condition and an ECOG status of 3 or 4 will not be included.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Objective: To evaluate the Effect on Cognitive Function

 		 Baseline 4weeks 8weeks 12weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the impact of Computerized Cognitive Intervention on the Quality of Life of individuals with brain tumors  BASELINE 4WEEKS 8 WEEKS 12 WEEKS  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   01/10/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  
Participants will be divided randomly into 2 groups. 
The control group will not be receiving the computerized intervention whereas the experimental group will be receiving the computerized intervention program. The study population will consist of patients with brain tumours who have completed the medical treatment at Tata Memorial Centre.
The Control group will receive Non-Computerized Interventions for a duration of 45 minutes/session, 3 sessions/week for 12 weeks which will include 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece non-computerized picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining. 
The Experimental Group will receive intervention for a duration of 45 + 30 minutes which will include Cognitive Interventions through Non-Computerized Intervention 1) Attention process Training including Letter Cancellation and Sorting Task.2) Restorative Approaches for Memory which will include 5-digit recall and Image recall 3) Problem Solving Training through the use of 10-piece picture puzzle. This group will also receive Deep Breathing Exercises, Conditioning Exercises and Motor Retraining. In addition, the experimental group will receive a 12-week cognitive intervention training program will involve the use of Cognifit which consists of cognitive facilitation games which are directed at Attention, Memory, Processing Speed and Executive Functions administered over three sessions per week where each session is of 30-minute duration. 
Evaluation of outcomes will be assessed at first visit and at end of every 4th week. Mean scores, percentages of cognitively impaired individuals will be compared between the groups. 
In addition, a feasibility form will be administered to obtain the feedback of the patient and caregiver users on the convenience of use of the app-based intervention program
Each participant is expected to available at the Occupational Therapy Outpatient Department for 3 sessions per week for 12 weeks. If you are in the control group, each session will last for about 45 minutes. If you are in the experimental group, each session would be for a duration of 45 and 30 minutes totaling to 1 hour 15 min. 
 
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