Behavior, Health
Conditions
Keywords
Meditation, Experienced meditators
Brief summary
To utilize positron emission tomography (PET) imaging to characterize the distribution of (aka \[11C\]APP311at the Yale PET Center) in cortical and subcortical areas in experienced meditators compared to non-meditating controls.
Detailed description
The investigators will conduct a PET study of the novel SV2A imaging tracer \[11C\]UCB-J in participants, to characterize the distribution of \[11C\]UCB-J in cortical and subcortical areas in experienced meditators compared to non-meditating controls. A total of up to 20 subjects will complete the study. Subjects will undergo one PET scan with \[11C\]UCB-J. Each subject will also undergo one MRI scan for anatomical identification of brain regions.
Interventions
DRUGRadiotracer
A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.
Sponsors
Yale University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 28-70 years * Voluntary, written, informed consent * Physically healthy by medical history, physical, ECG and laboratory examinations * At least 10 years and 5,000 hours of regular meditation practice * For females, non-lactating, no longer of child-bearing potential or agree to practice effective contraception during the study, as well as a negative serum pregnancy (β-HCG) test at screening, and negative urine pregnancy on PET scanning days.
Exclusion criteria
* A history of significant psychiatric, medical (e.g., cardiovascular, renal) or neurological (e.g., cerebrovascular, seizure, traumatic brain injury) illness that is unstable and/or might affect the study objectives. * Current or history of substance dependence (e.g., alcohol, nicotine, opiates, sedative hypnotics, etc.) * Subjects with history of prior radiation exposure for research purposes within the past year such that participation in this study would place them over FDA limits for annual radiation exposure. This guideline is an effective dose of 5 rem received per year. * Subjects with current, past or anticipated exposure to radiation in the work place within one year of proposed research PET scans that in combination with the study tracer would result in a cumulative exposure that exceeds recommended exposure limits. * Medical contraindications to participation in a magnetic resonance imaging procedure (e.g., ferromagnetic implants/foreign bodies, claustrophobia, cardiac pacemaker, prosthetic valve, otologic implant, etc.) * History of a bleeding disorder or are currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto). * Medications that effect SV2A binding (e.g., levetiracetam).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binding Potential Using Synaptic Density | Up to 6 months | Imaging data was analyzed using kinetic modeling approaches to quantitate total tracer binding, volume of distribution, and binding potential, specifically voxel-by-voxel compartment model fitting with the arterial input function. Positron emission tomography (PET) images will be registered to the subject's T1-weighted magnetic resonance (MR) images, and then registered to an magnetic resonance template. Gray matter regions of interest are determined by combining a predefined set of regions, defined on the template (FreeSurfer) with the gray matter segmentation mask (FAST algorithm in FSL). This process will permit direct, automatic determination of outcome values. Partial volume correction will also be applied to account for atrophy. Magnetic resonance (MR) image analyses will be done by standardized methods. Values reported for each region represent the binding potential. Binding potential is a unitless measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the Correlation Between Data Collected From Meditation Questionnaires and Synaptic Vesicle Glycoprotein 2 (SV2A) Binding | Up to 3 months | Meditation assessments collected from participants, containing mindfulness and attention measures, will be correlated with synaptic vesicle glycoprotein 2 (SV2A) binding data, collected during a positron emission tomography scan in the Anterior Cingulate Cortex. Data presented here is the correlation between Meditation years to SV2A availability. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Matuskey, MD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
None listed