EEG Changes With Guided Online Meditation

NCT03459690 | Completed Results

• 1 other identifier: 2018P000040
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Simple meditation and EEG changes

Conditions

Meditation

Keywords

Meditation, EEG

Outcome Measures

Primary Outcomes (1)

• Number of Participants With EEGs to Measure Changes in Wave Oscillations

  Number of participants who had EEGs to measure qualitative changes in wave oscillations

  6 weeks

Secondary Outcomes (2)

• Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude

  6 weeks

• Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency

  6 weeks

Study Arms (2)

Experienced meditators

EXPERIMENTAL

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

Behavioral: Meditation; Device: Enobio 32- EEG machine

Novice meditators

EXPERIMENTAL

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

Behavioral: Meditation; Device: Enobio 32- EEG machine

Interventions

Meditation 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.

Experienced meditators; Novice meditators

Enobio 32- EEG machine 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.

Experienced meditators; Novice meditators

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

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.

Results Point of Contact

• Title: Balachundhar Subramaniam
• Organization: Beth Israel Deaconess Medical Center

bsubrama@bidmc.harvard.edu

617-634- 2721

Study Officials

• Balachundhar Subramaniam

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Anesthesia Research Excellence

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 9, 2018
• Study Start: May 29, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 28, 2024
• Results First Posted: March 28, 2024

Record last verified: 2023-09

Locations

US (1)