EEG Changes With Meditation: A Proposal to Analyze EEG Changes With a Simple, Online, Guided Meditative Tool.
Phase: NA
Conditions: Meditation
Sponsor: Beth Israel Deaconess Medical Center

(CCI) Committee on Clinical Investigations 
Page 1 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
PART B 
STUDY DESCRIPTION 
 
TITLE OF PROTOCOL 
EEG changes with meditation: A proposal to analyze EEG changes 
with a simple, online, guided meditative tool 
Principal Investigator 
Balachundhar Subramaniam MD, MPH 
 
B1. 
PURPOSE OF PROTOCOL 
The purpose of this study is to assess: 
 
a) the qualitative EEG measures associated with meditation  
b) the observed difference in EEG changes between novice and experienced meditators 
c) the observed difference in EEG changes between the start and end of 6 weeks of daily meditation 
 
B2. 
SIGNIFICANCE AND BACKGROUND FOR THE STUDY 
 
Meditation refers to a category of self-regulation practices which focus on training attention and awareness in order 
to bring mental processes under greater voluntary control. Meditation, as therapy, has the potential to improve 
mental well-being and development in specific capacities such as calmness, clarity, and concentration.1 
Mindfulness is defined in psychological terms as being characterized by paying total attention to the present 
moment with a nonjudgmental awareness of inner and outer experiences.2  
 
Meditation and current literature: 
 
Studies have shown numerous benefits of meditation techniques. For example, Goyal et al. reported that meditation 
has a similar effect on anxiety and depression as compared to medication without the side effects.3 Therefore, it is 
essential to assess the usefulness of incorporating meditation as an adjunctive therapy in perioperative patient care.  
 
In order to study the benefits and efficacy of meditation intervention, it is important to have an objective measure 
that assesses the quality 
of meditation. Ahani et al. 
reported that EEG signals 
are sensitive to meditation 
using 
coherence 
and 
synchrony techniques as 
well as spectral analysis.4 
The 
overall 
effect 
of 
meditation is decreased 
electro-cortical 
arousal.5 
Meditators have shown to 
have higher alpha and 
theta activities in EEGs 
than 
non-meditators.6 
Focused-attention 
has 
shown to produce an 
increase 
of 
gamma 
activity in the brain. 
7 
Studies have also shown 
that meditation produces 
different 
activities 
at 
different locations such as 
increased alpha activity in 
frontal 
regions 
8 
and 
posterior regions.9  
 
 
EEG spectral analysis of alpha, beta, and theta waves during meditation. Credits :Ahani et al10 

(CCI) Committee on Clinical Investigations 
Page 2 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
 
A meta-analysis conducted in 2014 showed the most consistently altered brain regions were the left rostrolateral 
prefrontal cortex, anterior/mid cingulate cortex, anterior 
insula, primary/secondary somatomotor cortices inferior 
temporal gyrus, and hippocampus.11 Insula is consistently 
linked to interoception-awareness of the body’s internal and 
visceral states, including respiration, heart rate, emotional 
self-awareness, 
and 
potentially 
metacognitive 
awareness.12,13 Somatosensory areas are also altered by 
meditation. 
 
Neuroimaging studies have shown that there is increased 
cortical thickening in the left prefrontal lobe cluster as well as 
increased volume of insula, right temporal, and right angular 
gyrus.14 Meditators have also shown to have increased grey 
matter volume.  
 
Central box represents the value from the lower to upper 
quartile (25th to 75th percentile). The middle line represents 
the median. The vertical line extends from the minimum to 
the maximum value.14 
 
Experienced and novice meditators: 
A recent study has shown that after practicing 5-60 hours of 
meditation, 
novice 
meditators 
experience 
structural 
differences in 7 grey matters and 5 white matter tract regions.15 
 
Number 
Grey Matter areas 
White matter areas 
1) 
Anterior cingulate cortices 
Corpus callosum 
2) 
Posterior cingulate cortices 
Superior longitudinal fasciculus 
3) 
Insular cortex 
Sagital stratum 
4) 
Temporoparietal junction 
Thalamic radiation 
5) 
Hippocampus 
Corona radiata. 
6) 
Caudate nucleus 
 
7) 
Cerebellum 
 
 
A recently published study reports that meditation resulted in effortless awareness in novice and experienced 
meditators and meditation was associated with lower activity in Posterior Cingulate Cortices (PCC).15 A recent study 
has shown that meditation correlates with decreased activity of default mode network16 as opposed to an increased 
activity of default mode network associated with mind wandering and self-referential processes.17  
 
Network integration 
A recent study has also assessed the network integration in EEG due to meditation and has found that meditation is 
associated with increased brain network integration.15 Such studies demonstrate the possibility of application of real 
time EEG to associate an objective measure of brain activity with subjective mind states related to meditation. EEG 
has an excellent temporal resolution and is preferred over fMRI in this study since it is portable and less expensive.  
 
Meditation encompasses a family of complex practices that include yoga meditation, mindfulness meditation, 
mantra meditation, tai chi, etc. However, the training requirements for these types of meditation are variable 
including training from a trained teacher. Isha Kriya is a type of meditation that does not involve complicated 
trainings, rituals or mantras and can be performed anywhere at any time. Isha Kriya is a meditation technique that 
regulates breathing and produces a positive effect on the mind and body as endorsed by millions of people 
worldwide.18 At this time, no studies have been done regarding the EEG changes in the brain during Isha Kriya.  
 
This study will investigate if Isha Kriya produces EEG changes comparable to that of established literature and will 
look at the differences between the start and the end of a 6 week cycle. This study will also explore the difference in 
EEG changes between experienced and novice meditators. 

(CCI) Committee on Clinical Investigations 
Page 3 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
B3. 
DESCRIPTION OF RESEARCH PROTOCOL 
A. 
Study Design – Overview, Methods, Procedures 
 
Study design: 
This is a prospective trial enrolling healthy volunteers, including novice meditators and experienced meditators. 
Subjects will undergo an EEG at baseline and again after 6 weeks. During the 6 weeks, subjects will be asked to 
meditate twice a day, 12 minutes each time. 
 
Recruitment: 
Recruitment will occur via flyers posted at BIDMC and flyers emailed to mediation listservs. 
 
Study procedures: 
 
1) EEG 
Subjects will undergo an EEG at baseline and again after 6 weeks (+/- 1 week). During the EEGs, the subjects will 
be asked to meditate.  
 
The ENOBIO 32 EEG device is an investigational device under US federal law which is a 24-bit EEG data reader at 
the rate of 500 S/s which comes as a wearable wireless electrophysiology sensor system. It includes spectrogram 
and 3D visualization in real time of spectral features. It also collects triaxial acclereometer data. These data are 
stored in microSD offline in Holter mode.19 This EEG communicates via wireless allowing the subjects to be in a 
comfortable position and also can reduce the effects of electrical interference. EEG measures brain waves by the 
following processes: 
 
Pre-processing Signal 
Down sampling will be done to eliminate interference from unexpected signals. 
After down sampling, Band Pass Filter (BPF) will be used to filter the signals. 
 
Ensemble Average  
In this step, signal acquired from every selected channel would be averaged. There are fifteen signals 
from the instruction that are averaged into one signal representing the instruction. 
 
Short Time Fourier Transform (STFT) 
STFT will be used to determine a dominant frequency from the signal of an ensemble average 
result when the event occurs. 
 
Event Related Desynchronization/Event Related Synchronization  
ERD/ERS during event is calculated with the above data. 
 
2) Meditation 
 
Subjects will be introduced to Isha Kriya (IK) meditation. IK is a meditation that can be learned quickly and requires 
approximately 12 minutes, twice a day of practice. This regimen was chosen because of its simplicity making it an 
excellent way to introduce meditation to beginners. IK does not incorporate a spiritual or religious focus. Dr. 
Subramaniam, the principal investigator of the study, was trained to be an instructor by the Isha Institute of Inner 
Sciences, a nonprofit foundation located at McMinnville, Tennessee.  
 
At the time of enrollment, Dr. Subramaniam, or a trained research team member, will provide a brief introduction to 
IK meditation and review a handout of the meditation instructions. The subjects can utilize the online-guided 
meditation or follow the instructions on their own. 
 
Preparation: 
Sit in a cross-legged posture or sit in a chair, spine comfortably erect, hands upon 
thighs, palms facing up, face slightly upturned, eyes closed, keeping a mild focus 
between the eyebrows. 
Meditation: 
Slow inhaling and exhaling while mentally focusing on the words “I am not the body” 
and “I am not even the mind” for 7 minutes; uttering a long “Ahh” sound seven 
times; sitting for 5 minutes with eyes closed.  

(CCI) Committee on Clinical Investigations 
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Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
 
Subjects will be asked to practice the meditation twice daily for 12 minutes each session, for approximately 6 
weeks. They will be given a meditation diary to complete daily.  
 
 
 
Baseline 
After 6 weeks  
Group 1 - Novice meditators 
Meditation with EEG monitoring 
Meditation with EEG monitoring 
Group 2 - Experienced meditators 
Meditation with EEG monitoring 
Meditation with EEG monitoring 
 
 
Study Monitoring / Adverse Events: 
The study interventions are non-invasive and minimal risk. Therefore, we will limit the scope of AE monitoring and 
reporting to the following: 
 
• 
All Serious Adverse Events believed to be related to the study procedures 
• 
Unexpected, non-serious Adverse Events believed to be related to the study procedures 
 
 
B. Statistical Considerations 
a. Sample Size Justification:  In this pilot study, atleast10 patients who complete both EEGs are required 
for analysis.  In order to achieve this target accrual of 10 patients and also to account for potential 
dropouts, a total of 15 volunteers will be recruited. 
 
 
b. Data Analysis: Continuous data will be reported as means ± standard deviation or median (quartile 1, 
quartile 3) depending on distribution.  Normality will be assessed with the Shapiro-Wilk test.  Categorical 
data will be reported as frequencies and proportions and assessed with a chi-square of Fisher’s Exact test 
as appropriate.  SAS 9.4 (SAS Institute Inc., Cary, NC) will be used for all analyses, with two-sided p-
values < 0.05 considered statistically significant.   
The primary aim of the study is to study the effect of guided meditation on EEG. This will be a descriptive 
study noting the EEG changes (alpha vs beta), differences in the waveform signals between novices and 
experienced meditators, and at the beginning and the end of the 6-week period. 
Secondary analysis is 
being conducted with collaborators outside of BIDMC. Professor Contreras Vidal, Jose & his subordinate 
Sujatha Ravindran, Akshay from The University of Houston; will be assisting in the analysis of the EEG 
data collected. They will be provided with limited de-identified dataset in accordance to the terms of 
specific Data Use Agreements. No PHI will be shared between the institutions and all data will be 
completely de-identified before secure transfer to the co-investigators.  
 
Primary endpoint: 
1) Examine the qualitative EEG measures associated with Isha Kriya meditation  
 
Event related potential fields in EEG: amplitude in fT and latency in ms 
 
Oscillations: power spectral density and time-frequency oscillations in fT^2/Hz 
 
Secondary endpoints: 
 
1) Investigate the difference in EEG changes between novice and experienced meditators 
2) Investigate the difference in EEG changes between the start and end of 6 weeks of daily meditation 
 
 

(CCI) Committee on Clinical Investigations 
Page 5 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
C. 
Subject Selection 
 
This is a descriptive study of healthy volunteers, including novices and expert meditators. 
 
Inclusion criteria: 
1) 18 years or older  
2) Novice or expert meditator  
 
Novice meditator: No meditation practice in the previous year and < 20 entire lifetime hours 
Expert meditator: Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year 
 
 
 
Exclusion criteria: 
1) History of any neurological condition (i.e. Parkinson’s disease, Alzheimer’s disease, Huntington’s disease, 
brain tumors, brain surgery, or multiple sclerosis) 
2) History of depression, currently being treated with antidepressants 
3) History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, 
attention deficit hyperactive disorder) 
4) Current use of cognition enhancing medications 
5) Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week) 
6) History (within the last 5 years) of stroke/aneurysm 
7) Recent history (< 3 months) of seizures 
8) Non-English speaking 
 
Subject Protection 
Subjects will not be recruited on the basis of race, ethnicity, or gender. However, it is not clear whether the final 
study sample will contain a representative spread of the racial and gender makeup. There is no reason to exclude 
pregnant women from this protocol. 
 
 
B4. 
POSSIBLE BENEFITS 
We do not anticipate any direct benefit to be gained by the individual subject. Insights gained from this trial may 
allow us to better understand and interpret results and potentially provide information about the association 
between meditation and structural and functional brain changes. 

(CCI) Committee on Clinical Investigations 
Page 6 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
 
B5. 
POSSIBLE RISKS AND ANALYSIS OF RISK/BENEFIT RATIO 
Since this is a feasibility study on healthy individuals, and the intervention is non-invasive EEG, the risks expected 
to be associated with this study are minimum. 
 
EEG: 
Noninvasive EEG monitoring is considered a safe procedure. It has no discomfort and produces no sensation. In 
addition, there is no risk of electric shock. In rare instances, EEG can precipitate seizures in individuals with a 
seizure disorder due to flashing of lights or deep breathing.20 EEG will be performed by trained study staff.  
 
Meditation: 
The meditation intervention only involves thought and mindful breathing. We do not anticipate any physical risk. 
The meditation program has not been used in this arena prior to this study. Therefore, there is no published 
information regarding psychological risk. Additional counseling regarding any psychological or emotional distress 
stemming from this will be provided by the principal investigator at the request of the subject or family.  
 
Risk of breach of confidentiality: As with any research study, there is a small risk associated with a breach of 
confidentiality. All research staff for this trial has been extensively trained in how to handle confidential data and 
how to minimize the possibility of this risk. Data will be completely de-identified and transferred in a secure 
manner.   
 
Risk/Benefit Ratio: The meditation intervention has no expected risks and the knowledge gained could provide 
information about the association between meditation and structural and functional brain changes. Research team 
members will attempt to mitigate any of the possible risks described above.  
 
B6. 
RECRUITMENT AND CONSENT PROCEDURES 
 
Recruitment 
Subjects will be identified by the study team via response to study flyers seeking volunteers. Flyers will be posted 
throughout the Beth Israel Deaconess Medical Center. Flyers will also be sent to meditation listservs such as Isha. 
 
When interested subjects contact the study team, the study will be discussed and the subject will undergo 
prescreening for eligibility via phone. If the subject meets eligibility criteria, an appointment for the first EEG will be 
scheduled. 
 
Consent 
When the subject arrives at BIDMC for the first EEG, the study will be discussed and the consent form reviewed 
with a research team member. The subjects will have the opportunity to ask any and all questions, and are free to 
decline participation at any time. Written informed consent will be obtained prior to any research procedures. A 
copy of the signed consent will be provided to the subject and the original will be kept in the research files.  
 
The research team undergoes standardized, rigorous training regarding the informed consent process for 
research. Within the Center for Anesthesia Research Excellence (CARE) at BIDMC, this training is personally 
overseen by the Clinical Research Administrator and includes: didactic sessions, mandated attendance at 
CCI/HSPO seminars related to the informed consent process, shadowing of informed consent in a variety of 
contexts, trainee-led informed consent conversations with the aid of consenting checklists and accompanied by 
senior staff member and/or PI, robust feedback sessions, and clear communication when the team member is 
skilled enough to engage in informed consent discussions without direct supervision.  All CARE members, 
including non-physicians, undergo this training. 
 
Subject Protection 
This meditation regimen was chosen because it excels in simplicity and is a great way to introduce meditation to 
beginners. It does not incorporate a spiritual or religious focus. Subjects who are unable to consent for themselves 
will be excluded from this study.  
 
 

(CCI) Committee on Clinical Investigations 
Page 7 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
B7. 
STUDY LOCATION 
Privacy  
Study interactions and procedures will take place in private clinical settings with curtains/doors closed so as to 
provide privacy and comfort. Every effort will be made to protect the privacy of the participant.  
 
Physical Setting 
Subjects will be enrolled at BIDMC. Prescreening will occur via phone. Consent and EEGs will be performed in 
either the Clinical Research Center (CRC) or Pre-admission Testing (PAT) clinic. Electronic data will be 
maintained on password-protected computers behind the institutional firewall. Paper records will be maintained 
in locked file cabinets and secure research offices. 
 
B8. 
DATA SECURITY 
All electronic data will be stored in REDCap and/or on password-protected servers behind the BIDMC firewall. 
Any data collected on paper will be stored in locked file cabinets or in secure offices. Each subject will be 
assigned a study-specific ID number. A crosswalk between the participants and their study IDs will be 
maintained on password-protected computers by members of the research team. Limited information will be 
retained on patients who are prescreened and do not qualify, or who are approached and declined, for the 
purposes of generating a CONSORT diagram.  
Any transfer of data to outside collaborators will be done by sending Limited Data Sets with date-shifting, using 
Secure File Transfer. Data will be completely de-identified and transferred in a secure manner. The de-
identified data will be loaded in memory drive and/or DVD and send via trackable FedEx or using a Secure File 
Transfer online.  Recipients will work with the data on their secure institutional computers, behind a firewall. All 
data sharing will be done in accordance to the terms of BIDMC-issued Data Use Agreements. 
 
B9 
Multi-Site Studies 
N/A – not a multi-site study 
 
Is the BIDMC the coordinating site?    
 Yes  
 No  
Is the BIDMC PI the lead investigator of the multi-site study?   
 Yes  
 No  
 
B10 
Dissemination of Research Results 
Participants will be thanked for their time throughout the study. There is no plan to share the results at the 
conclusion of this trial.  
 
References: 
 
1. Walsh R, Shapiro SL. The meeting of meditative disciplines and Western psychology: a mutually enriching 
dialogue. Am Psychol 2006;61(3):227-39. 
2. Kabat-Zinn J. Wherever You Go, There You Are: Mindfulness Meditation In Everyday Life, 1994. 
3. Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological stress and well-being: a 
systematic review and meta-analysis. JAMA Intern Med 2014;174(3):357-68. 
4. Ahani A, Wahbeh H, Nezamfar H, et al. Quantitative change of EEG and respiration signals during 
mindfulness meditation. J Neuroeng Rehabil 2014;11:87. 
5. Delmonte MM. Electrocortical activity and related phenomena associated with meditation practice: a literature 
review. Int J Neurosci 1984;24(3-4):217-31. 
6. Fell J, Axmacher N, Haupt S. From alpha to gamma: electrophysiological correlates of meditation-related 
states of consciousness. Med Hypotheses 2010;75(2):218-24. 
7. Dunn AL, Marcus BH, Kampert JB, et al. Comparison of lifestyle and structured interventions to increase 
physical activity and cardiorespiratory fitness: a randomized trial. JAMA 1999;281(4):327-34. 
8. Takahashi T, Murata T, Hamada T, et al. Changes in EEG and autonomic nervous activity during meditation 
and their association with personality traits. Int J Psychophysiol 2005;55(2):199-207. 
9. Lagopoulos J, Xu J, Rasmussen I, et al. Increased theta and alpha EEG activity during nondirective 
meditation. J Altern Complement Med 2009;15(11):1187-92. 
10. Ahani A, Wahbeh H, Miller M, et al. Change in physiological signals during mindfulness meditation. Int IEEE 
EMBS Conf Neural Eng 2013:1738-381. 

(CCI) Committee on Clinical Investigations 
Page 8 of 8 
 
Study Description – Part B 
CCI Form: 9-2015 
 
PI Revision Date: 2020-03-03  
 
11. Tang YY, Hölzel BK, Posner MI. The neuroscience of mindfulness meditation. Nat Rev Neurosci 
2015;16(4):213-25. 
12. Critchley HD, Wiens S, Rotshtein P, et al. Neural systems supporting interoceptive awareness. Nat Neurosci 
2004;7(2):189-95. 
13. Fleming SM, Dolan RJ. The neural basis of metacognitive ability. Philos Trans R Soc Lond B Biol Sci 
2012;367(1594):1338-49. 
14. Hernández SE, Suero J, Barros A, et al. Increased Grey Matter Associated with Long-Term Sahaja Yoga 
Meditation: A Voxel-Based Morphometry Study. PLoS One 2016;11(3):e0150757. 
15. van Lutterveld R, Houlihan SD, Pal P, et al. Source-space EEG neurofeedback links subjective experience 
with brain activity during effortless awareness meditation. Neuroimage 2017;151:117-27. 
16. Brewer JA, Worhunsky PD, Gray JR, et al. Meditation experience is associated with differences in default 
mode network activity and connectivity. Proc Natl Acad Sci U S A 2011;108(50):20254-9. 
17. Mason MF, Norton MI, Van Horn JD, et al. Wandering minds: the default network and stimulus-independent 
thought. Science 2007;315(5810):393-5. 
18. Isha Kriya. Secondary Isha Kriya. http://www.ishafoundation.org/Ishakriya. 
19. ENOBIO 32. Secondary ENOBIO 32. http://www.neuroelectrics.com/products/enobio/enobio-32/. 
20. Electroencephalogram (EEG). Secondary Electroencephalogram (EEG). 
http://www.hopkinsmedicine.org/healthlibrary/test_procedures/neurological/electroencephalogram_eeg_92,P
07655/.