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CTRI Number  CTRI/2024/04/065384 [Registered on: 08/04/2024] Trial Registered Prospectively
Last Modified On: 06/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Deciphering expertise in meditation from neural signals 
Scientific Title of Study   EEG signatures of meditation proficiency among long-term meditators: An exploratory 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  Praerna Bhargav 
Designation  Senior Research Fellow 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Centre for consciousness studies Department of Neurophysiology NIMHANS Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9481202092  
Fax    
Email  praernabhargav@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Arun Sasidharan 
Designation  Scientist C 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Centre for consciousness studies Department of Neurophysiology NIMHANS Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  080-26972277  
Fax    
Email  arunsasi84@gmail.com  
 
Details of Contact Person
Public Query  
Name  Praerna Bhargav 
Designation  Senior Research Fellow 
Affiliation  National Institute of Mental Health & Neurosciences 
Address  Centre for consciousness studies Department of Neurophysiology NIMHANS Bangalore

Bangalore
KARNATAKA
560029
India 
Phone  9481202092  
Fax    
Email  praernabhargav@gmail.com  
 
Source of Monetary or Material Support  
Centre for Consciousness studies, Department of Neurophysiology, NIMHANS, Bangalore, Karnataka, 560029, India 
 
Primary Sponsor  
Name  Dr Ramajayam Govindaraj 
Address  Indian Knowledge System & Mental Health Center, Indian Institute of Technology, Mandi Kamand, Himachal Pradesh, 175005, India 
Type of Sponsor  Other [Academic & Research Institution] 
 
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 Praerna Bhargav  NIMHANS, Bangalore  Centre for Consciousness studies, Department of Neurophysiology, NIMHANS, Bangalore
Bangalore
KARNATAKA 		 9481202092

praernabhargav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
National Institute of Mental Health & Neurosciences  Approved 
Swami Vivekananda Yoga Anusandhana Samsthana  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy long-term Rajayoga meditators 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Observational study 
Intervention  Nil  Observational study on long-term meditators 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Meditators with minimum seven or more years of experience in Brahmakumaris Rajayoga meditation.
Ability to understand and speak English 
 
ExclusionCriteria 
Details  Subjects on any psychotropic medications
Substance use in the last one month or dependence in last 6 months
Practice of multiple meditation or yoga techniques in the past 6 months 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
meditation proficiency in terms of IaSC (across sessions) and ISC (across subjects) values obtained from Correlated Component analysis (CCA) of EEG power spectrum in long-term meditators during multiple meditation sessions on two different days
 		 Repeated Cross-sectional
Meditation session will be recorded twice in a day. Like this for two days 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of EEG power spectrum based proficiency measures between meditation & other conditions like rest & a cognitive task to find out if there is any comparative difference during conditions different from meditation
To find out if there is any correlation between EEG based proficiency measures with HRV outcomes & well-being related behavioral measures 		 Repeated Cross-sectional
Meditation session will be recorded twice in a day. Like this for two days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   20/04/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2044?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Novelty & Relevance of the study
Neural basis of meditative practices have interested many and studied extensively. Changes in neuronal signals during meditation has been widely studied. However, temporal consistency of these changes in neuronal signal has never been studied. For example, earlier studies have shown several EEG changes (in different modalities like spontaneous EEG oscillations, event related potentials, connectivity measures, etc.) among meditators compared to non-meditative controls. However, replicability of meditative mental state in the same subject on repeated occasions is yet to be explored. Replicability (temporal consistency) of electrophysiological signals (like EEG oscillatory changes) intentionally induced during meditation can be a neuro-marker for proficiency level of meditators. Such proficiency related neuro-markers can serve as reference gauge for the novice practitioners to improve their contemplative practices and the ensuing wellbeing effects. Hence, this study aims to assess replicability of mental state in EEG assessed brain oscillations during repeated meditation task performed by long-term meditation practitioners using EEG power spectrum based analysis strategies.
Further, long-term meditation practice is expected to enhance overall health & reflect the same in well-being.  And also neurological health has connections to cardiac health and the bi-directional influence of heart and brain on each other has a vital role in physiological, psychological and social health and thus overall well-being. HRV being a significant marker of cardiac health and autonomic functioning and not studied in RY meditators exclusively till date holds to be a potential measure of study. In addition, various meditation techniques including RY meditation has shown to improve various indices of well-being in independent studies but indexing its correlation with EEG measures and HRV in long-term meditators has not been assessed. Thus, this study also aims to assess HRV and well-being scores and their correlation with EEG measures in long-term meditators. Thus apart from identifying neuro-marker for meditation proficiency, addition of these measures can help in eliciting the translational value of proficiency in meditation in terms of autonomic functioning and well-being, adding to the novelty of the study. 
Study design
The study comprises of single arm with repeated cross-sectional design. Long-term Rajayoga meditators (with 7 or more years of experience in practicing meditation) will be recruited as per the inclusion exclusion criteria. After recruitment subjects will be called on two consecutive days. For data acquisition they will be instructed to sit comfortably on a chair with armrest and EEG will be acquired from each subject for three conditions – Meditation (M), Working memory (W) and Rest (R). Data for these three conditions will be acquired in the following order on two consecutive days: R-M-R—W—R-M-R (R - 4x4min; M - 2x15min; W - 1x15 min). 64-channel actichamp plus amplifier and brain recorder 1.23 (Brain Products, Germany) with an active electrode cap following 10/10 international system will be used for recording the data. Although primary aim of the study is to identify EEG signature for meditation related consistency in long-term meditators, subjects will also undergo rest and a cognitive task condition. Rest will be carried out in order to capture the baseline difference and cognitive task (W) being an objective task can act as a good comparator to measure consistency. 
Apart from EEG, lead-I ECG data will be collected by connecting one electrode on left arm and the second electrode on right arm. The number of heartbeats will be obtained using standard algorithm and the RR intervals will be used to derive HRV measures. The ECG data will be collected simultaneously with EEG.
In addition, well-being related behavioral measures will be assessed through questionnaires assessing Happiness index, Equanimity and WHO Well-being index.
Expected outcomes and implications of the study
The study findings will help in identifying whether long-term meditators can achieve consistent mental states during repeated meditation tasks. Also, this may lead to identification of an EEG based neuro-marker for meditation proficiency. Combined with other bio-signals and related behavioral measures, benchmark target could be developed for objective assessment of progress in meditation training across schools and can also be used to assess neural engagement in novice meditators.
 
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