EEG Changes With Guided Online Meditation

NCT ID: NCT03459690

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-29
• Study Completion Date: 2019-04-30

Brief Summary

Simple meditation and EEG changes

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experienced meditators

Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year

Group Type: EXPERIMENTAL

Meditation

Intervention Type: BEHAVIORAL

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 machine

Intervention Type: DEVICE

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.

Novice meditators

No meditation practice in the previous year and \< 20 entire lifetime hours

Group Type: EXPERIMENTAL

Meditation

Intervention Type: BEHAVIORAL

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 machine

Intervention Type: DEVICE

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.

Interventions

Meditation

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.

Intervention Type: BEHAVIORAL

Enobio 32- EEG machine

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Balachundhar Subramaniam

Director, Center for Anesthesia Research Excellence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Balachundhar Subramaniam

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018P000040

Identifier Type: -

Identifier Source: org_study_id