EEG Changes With Guided Online Meditation

Meditation Clinical Trial

— IKEEG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459690
• Other study ID #: 2018P000040
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: April 30, 2019

Study information

• Verified date: September 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Simple meditation and EEG changes

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meditation

Intervention

Behavioral:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	6 weeks
Secondary	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	6 weeks