Meditation
Conditions
Keywords
Meditation, EEG
Brief summary
Simple meditation and EEG changes
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, at least 12 minutes each time.
Interventions
BEHAVIORALMeditation
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.
DEVICEEnobio 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.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With EEGs to Measure Changes in Wave Oscillations | 6 weeks | Number of participants who had EEGs to measure qualitative changes in wave oscillations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude | 6 weeks | Number of participants who had evaluable EEGs to measure qualitative changes in wave amplitude |
| Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency | 6 weeks | Number of participants who had evaluable EEGs to measure qualitative changes in wave latency |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experienced Meditators Meditation ≥ 30 min per day for at least 5 days per week over the past 1 year
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 | 3 |
| Novice Meditators No meditation practice in the previous year and \< 20 entire lifetime hours
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 | 7 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Experienced Meditators | Novice Meditators | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 9 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 9.04 | 34.75 years STANDARD_DEVIATION 18.84 | 47.58 years STANDARD_DEVIATION 15.45 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 7 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 9 |
| other Total, other adverse events | 0 / 4 | 0 / 9 |
| serious Total, serious adverse events | 0 / 4 | 0 / 9 |
Outcome results
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
Time frame: 6 weeks
Population: Of the 13 participants enrolled in the study 2 participants requested withdrawal and 1 was lost to follow up, resulting in 7 novice meditators and 3 experienced meditators who completed the study. Following data cleaning for signal strength \& intensity among these 10 participants, only 7 participants (3 Experienced \& 4 Novice) had usable data for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experienced Meditators | Number of Participants With EEGs to Measure Changes in Wave Oscillations | 3 Participants with Evaluable EEGs |
| Novice Meditators | Number of Participants With EEGs to Measure Changes in Wave Oscillations | 4 Participants with Evaluable EEGs |
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
Time frame: 6 weeks
Population: Of the 13 participants enrolled in the study 2 participants requested withdrawal and 1 was lost to follow up, resulting in 7 novice meditators and 3 experienced meditators who completed the study. Following data cleaning for signal strength \& intensity among these 10 participants, only 7 participants (3 Experienced \& 4 Novice) had usable data for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experienced Meditators | Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude | 3 Participants |
| Novice Meditators | Number of Participants With Evaluable EEGs to Measure Changes in Wave Amplitude | 4 Participants |
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
Time frame: 6 weeks
Population: Of the 13 participants enrolled in the study 2 participants requested withdrawal and 1 was lost to follow up, resulting in 7 novice meditators and 3 experienced meditators who completed the study. Following data cleaning for signal strength \& intensity among these 10 participants, only 7 participants (3 Experienced \& 4 Novice) had usable data for analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experienced Meditators | Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency | 3 Participants |
| Novice Meditators | Number of Participants With Evaluable EEGs to Measure Changes in Wave Latency | 4 Participants |