IKEEG: EEG Changes With Guided Online Meditation

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03459690
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

Simple meditation and EEG changes

Condition or Disease	Intervention/Treatment	Phase
Meditation	Behavioral: Meditation; Device: Enobio 32- EEG machine	N/A

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, atleast minutes each time.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Other
• Official Title: EEG Changes With Meditation: A Proposal to Analyze EEG Changes With a Simple, Online, Guided Meditative Tool.
• Actual Study Start Date: May 29, 2018
• Actual Primary Completion Date: Apr 30, 2019
• Anticipated Study Completion Date: Apr 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experienced meditators Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year	Behavioral: 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; Device: Enobio 32- EEG machine; The ENOBIO 32 EEG device is an investigational device under US federal law which is a 24-bit EEG data reader which is a wearable wireless device
Experimental: Novice meditators No meditation practice in the previous year and < 20 entire lifetime hours	Behavioral: 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; Device: Enobio 32- EEG machine; The ENOBIO 32 EEG device is an investigational device under US federal law which is a 24-bit EEG data reader which is a wearable wireless device

Outcome Measures

Primary Outcome Measures

1. Qualitative EEG measure changes in wave oscillations [6 weeks]

   Changes in time-frequency oscillations of EEG waves in fT^2/Hz

Secondary Outcome Measures

1. Qualitative EEG measure changes in wave amplitude [6 weeks]

   Changes in amplitude of EEG waves in fT

2. Qualitative EEG measure changes in wave latency [6 weeks]

   Changes in latency of EEG waves in ms

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• Beth Israel Deaconess Medical Center

Investigators

• Principal Investigator: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Balachundhar Subramaniam, Director, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT03459690
• Other Study ID Numbers: 2018P000040
• First Posted: Mar 9, 2018
• Last Update Posted: Feb 2, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Balachundhar Subramaniam, Director, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center: Meditation, EEG

Study Results

No Results Posted as of Feb 2, 2021