Clinical trial NCT05418608: Novel in Vivo Synaptic Imaging in Experienced Meditators
Official title: Novel in Vivo Synaptic Imaging in Experienced Meditators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Behavior, Health
Keywords: Meditation
Experienced meditators
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 28
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Analyzing positron emission tomography images in conjunction with magnetic resonance data
timeFrame: Up to two years
Secondary outcomes:
measure: Evaluating the correlation between data collected from meditation questionnaires and synaptic vesicle glycoprotein 2 (SV2A) binding
timeFrame: Up to two years
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University PET Center
state: Connecticut
Study officials:
affiliation: Yale University
name: David Matuskey, MD
role: PRINCIPAL_INVESTIGATOR
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