Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT01301105
Eligibility Criteria:
Inclusion Criteria:
1.1 Risk Factors
* Able to lie still in the scanner for 90 minutes
* Weighs under 300 pounds
1.2 Factors impacting on the outcome measures
* 18-65 years old
* Right-handed
* No previous experience with meditation.
* No daily practice with other mind-body techniques (e.g., yoga, tai-chi, but previous exposure to yoga is okay)
* In good general health as determined by the investigator
1.3 Logistic Issues
* Able to walk
* Able to understand and speak English
* Able to provide written consent prior to admission
* Able to see without glasses (as if looking through binoculars)
Exclusion Criteria:
2.1 Risk Factors
* Any metallic implants, such as prostheses that cannot be removed, aneurysm clip-S, dental or orthodontic (filings are okay), or orthopedic (e.g., pins, rods, screws, nails) \[okay with doctors note\]
* Any electronic implants, such as cardiac pacemakers, cardiac defibrillator, artificial heart valve, cardiac pace wires,
* Lens implants prior to 1983
* Breast/penile, electrodes, neurostimulators/biostimulators, pumps (e.g. drug infusion device), bone or socket implants (Check with PI or MR technician)
* Any type of prosthesis
* Any permanent cosmetics (e.g., eyeliner) prior to 1975
* Any tattoos on upper body prior to 1975
* Any irremovable non plastic body piercing(s)
* Has ever worked as an occupational metal grinder without protective glasses
* Has ever worked with metal as a hobby without protective glasses
* Has ever had or sought medical attention for metal in the eyes \[requires orbit x-ray\]
* Has ever has metal fragments removed from eyes \[requires orbit x-ray\]
* Has ever been struck by a gun shot, B.B. or shrapnel, and the bullet stuck \[judgement\]
* Has a history of any metal in body
* Diabetes
* Peripheral vascular disease, peripheral arterial disease, Raynaud's disease, or any other diagnosed circulatory disorders
* Body mass index (BMI) below 18.5
* Any involuntary motor disorders
* Has a cochlear implant
* Wears a hearing aid that cannot be taken out (Check with PI or MR technician)
* Wears a hearing aid
* Wears dentures that cannot be removed or contain metal
* A subject who is claustrophobic
* A female subject who is pregnant or has an intrauterine device (IUD)
* Allergic to adhesive tape
* A history of problems of any kind during blood draws
* Women who may be pregnant
* Women who have an intrauterine device (IUD) \[okay with a doctors note\]
* 2 or more of the following \[judgment\]
* Diagnosed hypertension?
* Hyperlipidemia
* High cholesterol
* Obesity can be calculated from weight \& height info.
* Smoke cigarettes
* Family history of coronary or atherosclerotic disease (parents/siblings prior to age 55)
2.2 Factors impacting on the outcome measures
* Current medical disorders that might make interpretation of scan data difficult
* Has a problem with alcohol or non prescription drugs
* Use of medications that affects CNS function, including psychotropics, opiate medication or corticosteroids, during the last 3 months
* Any prescribed psychotropic medications, currently or during the last 3 months (These include medications for anxiety, depression, or other psychological problems)
* Plans to start taking any prescribed psychotropic medications
* Takes inhaled steroids for asthma? (e.g., Fluticasone)
* Takes any corticosteroids?
* Night shift workers (11 pm to 7 am) d/t potential disruption of cortisol level variability
* Diabetes requiring insulin treatment
* Has TMJ (Temporal Mandibular Joint) disorder or other problems with biting/chewing
* Previous training in meditation
* Currently meditates on a regular basis
* Daily yoga, tai-chi, or Qigong practice
* Engagement in moderate sport and recreational activities more than 5 times a week
* Engagement in vigorous sport and recreational activities more than 4 times a week
2.3 Logistic Issues
* Phobia of needles
* Not able to attend an informational session, all class meetings, and all clinic visits
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01301105
Study Brief:
Protocol Section:
NCT01301105