Examining the effects of social disconnection on the brain
Role of Synaptic Density in Mediating the Relation Between Social Disconnection and Late-life Suicide Risk
Yale University · NCT06705348
This study is testing how feelings of loneliness and isolation affect the brains of people aged 55 and older over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Yale University (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT06705348 on ClinicalTrials.gov |
What this trial studies
This research investigates how social connectedness, particularly feelings of loneliness and isolation, affects synaptic density in the brain. Participants aged 55 and older will undergo various imaging procedures, including MRI, PET, and EEG scans, to assess brain activity and structure. The study includes follow-up assessments over a period of up to five years to monitor changes in mood and cognition. The goal is to better understand the neurological impacts of social disconnection.
Who should consider this trial
Good fit: Ideal candidates are English-speaking individuals aged 55 and older who can provide informed consent.
Not a fit: Patients with serious medical or neurological illnesses, or those with contraindications to MRI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the neurological effects of social isolation, potentially leading to improved interventions for loneliness.
How similar studies have performed: While studies on social disconnection exist, this specific approach using advanced imaging techniques to assess brain changes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * able to give written informed consent * age 55+ * English speaking Exclusion Criteria: * contraindication to MRI scanning including claustrophobia, high girth, moderate to significant white matter atrophy, and presence of ferromagnetic material in the body, including orthodontic braces or other non MR-compatible foreign bodies. All participants will be screened for metal objects by the same methods used for routine clinical MRI scanning * for women: pregnancy or breastfeeding * serious medical or neurological illness that in the opinion of the PI would interfere with the scientific goals of the study or participant safety * pervasive developmental disorders (PDD) or primary psychotic disorders * meet DSM-5 criteria for current severe substance use disorder (except marijuana or nicotine) * head injury that led to significant long term decline in cognitive abilities as seen by decline in grades or work performance * current psychosis, active significant suicidal (score of 6 on MADRS suicide item) or homicidal ideation * lifetime history of neurologic abnormality including seizure disorder, cerebrovascular, or neoplastic lesion, neurodegenerative disorder, or significant head trauma resulting in post-traumatic amnesia \>24 hours * full scale IQ lower than 70 * contraindications to PET (e.g. poor venous access for placement of venous lines) * 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 * history of a bleeding disorder or currently taking anticoagulants (such as Coumadin, Heparin, Pradaxa, Xarelto) \*for subjects obtaining arterial line. * blood donation within 8 weeks of the start of the study * REM sleep disorder * brain injury (TBI, seizure/epilepsy, stroke, TIA) in lifetime (self-report and medical chart review) * electroconvulsive or ketamine therapy, or similar therapies that have rapid effects on brain neurochemistry within the past 6 months * high risk for stroke (above first quartile on Framingham Stroke Risk Profile) * current cancer
Where this trial is running
New Haven, Connecticut
- Yale Translational Brain Imaging Program — New Haven, Connecticut, United States (RECRUITING)
Study contacts
- Principal investigator: Irina Esterlis, Ph.D. — Yale University
- Study coordinator: Sarah Boster, MA
- Email: Sarah.debonee@yale.edu
- Phone: 203-737-7066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Social Disconnection, loneliness, social disconnection, isolation