Yale Translational Brain Imaging Program
New Haven, Connecticut, 06510, United States
Location status: Recruiting
Location contact
Irina Esterlis, Ph.D.
PRINCIPAL_INVESTIGATOR
Nicole DellaGioia, MA
CONTACT
Sarah Boster, MA
CONTACT
NCT Number: NCT06705348
The purpose of this research study is to examine the effect of social connectedness on the brain. Study procedures include one Magnetic Resonance Imaging (MRI) or functional Magnetic Resonance Imaging (fMRI) scan, one Positron Emission Tomography (PET) scan, one Magnetic Resonance Spectroscopy (MRS) scan, an electroencephalogram (EEG), and in-person and phone call follow-ups.
Interested in participating?
Request Info55 year and older
All sexes
Observational
New Haven, Connecticut, 06510, United States
Location status: Recruiting
Irina Esterlis, Ph.D.
PRINCIPAL_INVESTIGATOR
Nicole DellaGioia, MA
CONTACT
Sarah Boster, MA
CONTACT
The purpose of this study is to examine the effect of social connectedness (social isolation and loneliness) on synaptic density in the brain using PET scans. Participants will have a screening appointment to determine eligibility. Participants will participate in the following study procedures:
MRI or fMRI scan: the purpose of the MR scan is to help us identify the different regions of the brain on the PET scans. Participants may be asked to do some cognitive and behavioral tasks during parts of the MR scan.
PET scan: an arterial catheter and one or two IV catheters will be placed (one for radiotracer injection and one to take blood samples). The radiotracer, [18F]SDM-8 will be used. A radiotracer is a minimal amount of a drug that is labeled with a very small amount of a radioactive substance that binds to receptors in the brain and can be detected by a special camera in the PET scanner.
Electroencephalography (EEG): EEG is a procedure that allows measurement of physiological brain responses. Sensors placed on and around the head record small electrical currents produced by the brain.
Follow-up phone calls and appointments: participants will have follow-up phone calls every 3 months for 9 months following scan visits, and an in-person follow-up appointment 1 year after scans to assess mood and cognition, as well as document any changes. Follow-up assessments may continue for up to 5 years after the year one follow-up appointment.
Some subjects may be asked to return after the 1 year follow-up period to repeat study procedures to examine changes over time.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: enrollment to end of study participation (approximately 1 year)
Social disconnection composite measure determined by the following:
Item #3 - Hamilton Depression Rating Scale (social withdrawal; range = 0-4) Item #12 - Beck Depression Inventory-II (loss of interest in people; range = 0-3) Item #14 - Center for Epidemiologic Studies Depression Scale (feelings of loneliness; range = 0-3) Item #2 - Snaith-Hamilton Pleasure Scale (enjoyment being with family or close friends; range = 0-1) Item #7 - Snaith-Hamilton Pleasure Scale (enjoyment seeing other people's smiling faces; range = 0-1) Item #17 - Profile of Mood States (loneliness; range = 0-4)
Higher composite score = greater severity of social disconnection.
Time frame: enrollment to end of study participation (approximately 1 year)
SV2A density as measured using [18F]SDM8 PET imaging.
Time frame: enrollment to end of study participation (approximately 1 year)
Suicide risk will be operationalized as a composite score of death ideation, depressive symptoms, loss of personal and self-worth, executive control, and perceived meaning in life based on the following:
Geriatric Suicide Ideation Scale (GSIS) suicide ideation subscale score (range 10-50, higher score indicates greater active suicidal ideation).
GSIS death ideation subscale score (range 5-25, higher score indicates greater death ideation) Montgomery Asberg Depression Rating Scale (MADRS) total score (range 0-60, higher score indicates greater severity of depression) GSIS loss of personal and social worth subscale score (range 7-35, higher score indicates greater feeling of loss of personal and social worth) Cogstate Go/No-Go task score GSIS perceived meaning in life subscale score (range 8-40, higher score indicates lower perceived meaning in life)
Time frame: enrollment to end of study participation (approximately 1 year)
Time frame: 12-month study period (from scanning to year 1 follow-up)
identification of predominant trajectories of suicide risk measures (see 'composite measure of suicide risk' outcome measure) over 5 time points spanning the 12-month study period (0, 3, 6, 9, and 12 months).
Contact information is provided by the study sponsor or research team.
Nicole DellaGioia, MA
CONTACT
Sarah Boster, MA
CONTACT
Yale University
Other
Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06269146
Anxiety, Anxiety Disorders
San Diego, California, United States
View Trial DetailsNCT05310747
Chronic Pain, Neurologic Manifestations
Sacramento, California, United States
View Trial Details