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EEG Changes With Guided Online Meditation (IKEEG)

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ClinicalTrials.gov Identifier: NCT03459690
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Balachundhar Subramaniam, Beth Israel Deaconess Medical Center

Brief Summary:
Simple meditation and EEG changes

Condition or disease Intervention/treatment Phase
Meditation Behavioral: Meditation Device: Enobio 32- EEG machine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

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




Primary Outcome Measures :
  1. Qualitative EEG measure changes in wave oscillations [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Changes in amplitude of EEG waves in fT

  2. Qualitative EEG measure changes in wave latency [ Time Frame: 6 weeks ]
    Changes in latency of EEG waves in ms



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459690


Contacts
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Contact: Balachundhar Subramaniam, MD, MPH 617-634-2721 bsubrama@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Balachundhar Subramaniam, MD    617-754-2675    bsubrama@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Balachundhar Subramaniam Beth Israel Deaconess Medical Center

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Responsible Party: Balachundhar Subramaniam, Director, Center for Anesthesia Research Excellence, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03459690     History of Changes
Other Study ID Numbers: 2018P000040
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Balachundhar Subramaniam, Beth Israel Deaconess Medical Center:
Meditation, EEG