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CTRI Number  CTRI/2024/02/062695 [Registered on: 15/02/2024] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study if brain training helps in depression 
Scientific Title of Study   To study the effect of neurofeedback training on depression scores and prefrontal cortical activity in depression: a randomized control study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kanika 
Designation  post graduate student, MSc. Medical Physiology 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Physiology, AIIMS Nagpur, Maharashtra, India

Nagpur
MAHARASHTRA
441108
India 
Phone  8826363922  
Fax    
Email  kanikatiwari27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mrunal Phatak  
Designation  Professor and HOD, Department of physiology, AIIMS, Nagpur 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Physiology, AIIMS Nagpur, Maharashtra, India


MAHARASHTRA
441108
India 
Phone  8826363922  
Fax    
Email  phatakms@gmail.com  
 
Details of Contact Person
Public Query  
Name  Kanika 
Designation  post graduate student, MSc. Medical Physiology 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  Department of Physiology, AIIMS Nagpur, Maharashtra, India


MAHARASHTRA
441108
India 
Phone  8826363922  
Fax    
Email  kanikatiwari27@gmail.com  
 
Source of Monetary or Material Support  
All India Institute ofMedical Sciences,Nagpur, Maharashtra, India 
 
Primary Sponsor  
Name  AIIMS,Nagpur 
Address  Department of Physiology, AIIMS Nagpur 
Type of Sponsor  Research institution and hospital 
 
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 Mrunal Phatak  AIIMS, Nagpur  Room 118, Cognitive neurophysiology lab,Department of physiology,Medical college building,AIIMS, Nagpur, Maharashtra, India
Nagpur
MAHARASHTRA 		 9822560037

phatakms@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,AIIMS,Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F330||Major depressive disorder, recurrent, mild, (2) ICD-10 Condition: F331||Major depressive disorder, recurrent, moderate, (3) ICD-10 Condition: F320||Major depressive disorder, singleepisode, mild, (4) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Neurofeedback training  Patients diagnosed with depression attending Psychiatry OPD of AIIMS,Nagpur who satisfy the inclusion and exclusion criteria will be included.The patient will be asked to sit in front of a screen of 19 inches at 60 cm. The patient will be shown in own real time prefrontal cortical activity (HbO levels). Where, more red means the area is active (more HbO) while blue means the area is inactive. The patient will be instructed to focus on this activity so that the area becomes more red. Some strategies (like calculations, navigating through a place, remembering autobiographical happy memories etc.) which can help them to increase their pre frontal cortical activity will be provided by the investigator however they will also be asked to use any other strategy which seems helpful to them. Note of which activity they are using will be done after every session. Initially the participants will be given practice rounds to learn. Once the patient starts modulating his prefrontal cortical activity the neurofeedback session will be started. The sessions will consist of 30 seconds rest - 30 seconds activation - 30 seconds rest. There will be 20 such trails. 
Comparator Agent  Sham training  Patients diagnosed with depression (by a psychiatrist) attending the Psychiatry OPD of AIIMS,Nagpur who satisfy the inclusion and exclusion criteria will be incuded. In sham training also the patient will be asked to sit in front of the screen similar to the neurofeedback training group. However the neurofeedback sessions will not have the activation part of their own cortical activity in the trials. Instead the sessions will consist of 30 seconds rest followed by 30 seconds of looking at prefrontal cortical activity of another participant (from neurofeedback group) on the screen. The sham trial will also consist of 20 such trials. Thus, the sham training will mimic the same settings without the active cognitive component in it. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Age 18-55 years both genders, Diagnosis according to ICD 10 by psychiatrist, HDRS score equal to or more than 8, ongoing treatment for atleast 4 weeks or more, normal or corrected to normal vision, normal colour vision assessed by ishihara chart 
 
ExclusionCriteria 
Details  Any history secondary causes of cognitive impairment (like history of stroke, brain injury, psychosis, exposure to toxins, substance abuse, history of neurological disease, dementia, Alzheimer’s disease or any neurological illness with significant cognitive impairment). Dementia will be ruled out with MoCA score ≤18 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the effect of 4-weeks of fNIRS based neurofeedback training on depression scores, resting and cognitive task based prefrontal cortical activity in depression  Day 1 (Baseline),
Day 29 (Post intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess whether the antidepressant effects of neurofeedback training on depression scores lasts even after 4 weeks of completion of training  Depression scores on day 0
Depression scores on day 57 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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 3 
Date of First Enrollment (India)   20/02/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

The study aims to explore the use of functional near-infrared spectroscopy (fNIRS) as a tool for neurofeedback training in depression. The study is a single-center, open-label, randomized trial conducted at the Cognitive Neurophysiology Lab, Department of Physiology, All India Institute of Medical Sciences, Nagpur. It aims to investigate the effect of neurofeedback training on prefrontal cortical activity in adults with depression. Participants will be recruited from the Department of Psychiatry and will be given ID codes to maintain confidentiality. The study will have two groups: Group A (Neurofeedback training) and Group B (Sham training), with all patients receiving standard care of treatment. The neurofeedback training will involve participants modulating their prefrontal cortical activity based on real-time feedback, while the sham training will mimic the same settings without the active cognitive component.Neurofeedback training involves the patient sitting in front of a screen displaying their real-time prefrontal cortical activity (HbO levels) using functional near-infrared spectroscopy (fNIRS). The patient is instructed to focus on this activity and attempt to modulate it, with the sessions consisting of 30 seconds of rest, 30 seconds of activation, and 30 seconds of rest, repeated 20 times. The patient is provided with strategies to increase prefrontal cortical activity and is given practice rounds to learn before starting the neurofeedback session.

Sham training also requires the patient to sit in front of a similar screen, but the sessions do not include the activation part of their own cortical activity. Instead, the sessions consist of 30 seconds of rest followed by 30 seconds of observing the prefrontal cortical activity of another participant from the neurofeedback group, also repeated 20 times. This mimics the same settings as neurofeedback training but without the active cognitive component.

The study aims to assess the impact of these interventions on depression scores and prefrontal cortical activity, with the neurofeedback training group expected to show improvements in these measures compared to the sham training group. The study will also evaluate the duration of the antidepressant effects of neurofeedback training beyond the 4-week training period.

The study will use functional near-infrared spectroscopy (fNIRS) to measure prefrontal cortical activity, and statistical analysis will be conducted using ANOVA and Krusall wallis tests. The study will have no blinding, and participants will be free to withdraw from the study at any stage without penalty. The data collected will be encrypted and stored locally and on cloud/online backup to maintain confidentiality.


 
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