Social Disconnection Study (NCT06705348) | Clinical Trial Compass
RecruitingNot Applicable
Social Disconnection Study
United States100 participantsStarted 2023-05-08
Plain-language summary
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.
Who can participate
Age range
55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Social disconnection
Timeframe: enrollment to end of study participation (approximately 1 year)
2
SV2A density
Timeframe: enrollment to end of study participation (approximately 1 year)