MeditationIKEEGNCT03459690

EEG Changes With Guided Online Meditation

A study testing Meditation and Enobio 32- EEG machine in people with Meditation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Simple meditation and EEG changes Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Meditation
What is being tested?: Meditation and Enobio 32- EEG machine
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13 participants
Where: 1 siteUnited States
Study dates: 29 May 2018to 30 Apr 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 years or older
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

Who cannot join

History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
History of depression, currently being treated with antidepressants
History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
Current use of cognition-enhancing medications
Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week)
History (within the last 5 years) of stroke/aneurysm
Recent history (< 3 months) of seizures
Non-English speaking

Trial locations and contacts

1 site in 1 country.

United States1 site

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: EEG Changes With Meditation: A Proposal to Analyze EEG Changes With a Simple, Online, Guided Meditative Tool.

Simple meditation and EEG changes

Read the detailed description

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, at least 12 minutes each time.

Conditions: Meditation
Being tested: Meditation, Enobio 32- EEG machine
Keywords: Meditation, EEG

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MeditationBehavioural
Isha Kriya meditation is simple meditation practice which can be easily learned by employing online guided tools. Isha Kriya meditation 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. Isha Kriya does not incorporate a spiritual or religious focus.
Enobio 32- EEG machineDevice
This study utilizes the Enobio 32 EEG device made by Neuroelectrics (an FDA-cleared 24-bit EEG data reader which is a wearable wireless device) to analyze EEG changes after subjects have undergone meditation. This study does not evaluate the Enobio device, and the IRB of record approved an Investigational Device Exemption for this study.

Study groups in NCT03459690
Study group	Role	What they receive
Experienced meditators	Experimental	Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year Receives: Behavioral: Meditation; Device: Enobio 32- EEG machine
Novice meditators	Experimental	No meditation practice in the previous year and < 20 entire lifetime hours Receives: Behavioral: Meditation; Device: Enobio 32- EEG machine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With EEGs to Measure Changes in Wave Oscillations
Number of participants who had EEGs to measure qualitative changes in wave oscillations
Measured: 6 weeks

Secondary outcomes (2)

Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude
Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude
Measured: 6 weeks
Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency
Number of participants who had evaluable EEGs to measure qualitative changes in wave latency
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 May 201830 Apr 2019

First posted9 Mar 2018
Study start29 May 2018
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for MeditationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03459690
Sponsor's protocol ID: 2018P000040
Acronym: IKEEG
Status last verified: Sep 2023
First submitted: 14 Feb 2018
Last updated: 28 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meditation trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EEG Changes With Meditation: A Proposal to Analyze EEG Changes With a Simple, Online, Guided Meditative Tool.
ClinicalTrials.gov ID: NCT03459690
Acronym / sponsor ID: IKEEG / 2018P000040
Conditions: Meditation
Keywords: Meditation, EEG
Study type: Interventional
Recruitment status: Completed
Enrolment: 13 participants (actual)
Lead sponsor: Beth Israel Deaconess Medical CenterUniversity, hospital or other
Study start: 29 May 2018 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 9 Mar 2018 (actual)
Results: Posted 28 Mar 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Simple meditation and EEG changes

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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.

Arm	Type	Receives
Experienced meditators	Experimental	Behavioral: Meditation, Device: Enobio 32- EEG machineMeditation ≥ 30 min per day for at least 5 days per week over the past 1 year
Novice meditators	Experimental	Behavioral: Meditation, Device: Enobio 32- EEG machineNo meditation practice in the previous year and < 20 entire lifetime hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18 years or older
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

Key exclusion criteria (8 listed)

History of any neurological condition (i.e. Parkinson's disease, Alzheimer's disease, Huntington's disease, brain tumors, brain surgery, or multiple sclerosis)
History of depression, currently being treated with antidepressants
History of any psychiatric disorder, within last 5 years (i.e. anxiety, psychosis, posttraumatic stress disorder, attention deficit hyperactive disorder)
Current use of cognition-enhancing medications
Active history (within the last 5 years) of alcohol or drug abuse (> 10 drinks per week)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MeditationIsha Kriya meditation is simple meditation practice which can be easily learned by employing online guided tools. Isha Kriya meditation 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. Isha Kriya does not incorporate a spiritual or religious focus.	Behavioural	Experienced meditators, Novice meditators
Enobio 32- EEG machineThis study utilizes the Enobio 32 EEG device made by Neuroelectrics (an FDA-cleared 24-bit EEG data reader which is a wearable wireless device) to analyze EEG changes after subjects have undergone meditation. This study does not evaluate the Enobio device, and the IRB of record approved an Investigational Device Exemption for this study.	Device	Experienced meditators, Novice meditators

Primary outcome

Number of Participants With EEGs to Measure Changes in Wave Oscillations
Time frame: 6 weeks
Number of participants who had EEGs to measure qualitative changes in wave oscillations

2 secondary outcomes

Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude
Time frame: 6 weeks
Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency
Time frame: 6 weeks

Results and safety

Results posted to the registry on 28 Mar 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experienced Meditators	4	3
Novice Meditators	9	7

Primary outcome: Number of Participants With EEGs to Measure Changes in Wave Oscillations

Time frame: 6 weeks. Number. Unit: Participants with Evaluable EEGs

Measure	Experienced Meditators n = 3	Novice Meditators n = 7
Value	3	4

Population analysed: Of the 13 participants enrolled in the study 2 participants requested withdrawal and 1 was lost to follow up, resulting in 7 novice meditators and 3 experienced meditators who completed the study. Following data cleaning for signal strength \& intensity among these 10 participants, only 7 participants (3 Experienced \& 4 Novice) had usable data for analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experienced Meditators	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Novice Meditators	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): 1. The total number of participants enrolled in the study (n=13) was small, which means that the strength of the statistical test will be low. 2. Participant numbers with evaluable EEG was even smaller. Hence, group level analysis could not be performed in the study and the effects were assessed at an individual level. 3. Technical issues such as bad channels, corrupt data files and missing files marred the collected data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Recruiting
Efficacy of the MAEva Program (Meditation, Acceptance, and Commitment to Values) Among Patients Treated For Breast Cancer.
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Recruiting
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Recruiting
Digital Mindfulness Meditation in Adolescents With Atopic Dermatitis
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Balachundhar Subramaniam principal investigator

Beth Israel Deaconess Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Meditation and Enobio 32- EEG machine in people with Meditation, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With EEGs to Measure Changes in Wave Oscillations (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03459690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.