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Completed

NCT Number: NCT03459690

EEG Changes With Guided Online Meditation

Simple meditation and EEG changes

Completed

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Key information

Conditions

Meditation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Number of Participants With EEGs to Measure Changes in Wave Oscillations

    Time frame: 6 weeks

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

Secondary outcomes

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

    Time frame: 6 weeks

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

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

    Time frame: 6 weeks

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

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Acronym: IKEEG

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 9, 2018
Registry last updated
Mar 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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