Novel in Vivo Synaptic Imaging in Experienced Meditators

Study Overview
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Brief Summary
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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
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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.

Official Title
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Novel in Vivo Synaptic Imaging in Experienced Meditators

Conditions
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Behavior, Health

Intervention / Treatment
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* Drug: Radiotracer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 28 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aim 1<br>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. Subjects will undergo one PET scan with [11C]UCB-J and one MRI scan for anatomical identification of brain regions. | Drug: Radiotracer<br>* A novel SV2A imaging tracer which is used in conjunction with positron emission tomography scans.<br>* Other names: [11C]UCB-J;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyzing positron emission tomography images in conjunction with magnetic resonance data | Imaging data will be analyzed by using kinetic modeling approaches; these are used 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 (Anatomical Automatic Labeling (AAL) for SPM2) 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. | Up to two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating the correlation between data collected from meditation questionnaires and synaptic vesicle glycoprotein 2 (SV2A) binding | 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. | Up to two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meditation, Experienced meditators