NCT06029348 · University of Pittsburgh
Cerebrovascular Health and Resilience in Midlife
(CHARM)
What this study is about
This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview.
View original scientific description
This study examines cardiovascular responses to a brief psychological challenge under laboratory conditions among adult volunteers. The study volunteers are asked to complete two study sessions. In one session, the volunteers are asked to provide demographic and health-related information via questionnaires and an interview. In that session, volunteers would then be asked to undergo evaluations of their body composition, blood pressure, heart rate, and other signs of cardiovascular function and health. Lastly, volunteers would be asked to take part in a brief and challenging psychological task after a period of rest while cardiovascular activity is measured. In the other session, volunteers are asked to undergo magnetic resonance imaging and to complete neuropsychological tests of memory, attention, and processing speed. In addition to these two sessions, volunteers are asked to complete online questionnaires. The study is designed to examine associations between transient changes in cardiovascular activity induced by the psychological task, measures of overall cardiovascular health, and measures of cerebrovascular health measured by magnetic resonance imaging. Study results are expected to provide new information about the relationships between cardiovascular activity changes to psychological challenges and cardiovascular and cerebrovascular health in adults.
Interventions
BEHAVIORAL
Paced Auditory Serial Addition Task
Study volunteers will be asked to complete a 4-minute Paced Auditory Serial Addition Task, which is a standardized task that is widely used to study cardiovascular responses to acute psychological challenges (or stressors) in a laboratory setting.
Primary outcome measures
Change in systolic blood pressure (SBP) from baseline to task
Time frame: Mean SBPs for the computation of change scores will be computed from the average of the 5 min baseline period and average of the 4 min task period
The mean SBP from the baseline period will be subtracted from the mean of the task period.
White matter hyperintensity burden
Time frame: Derived from one acquisition sequence within in a 50 min multimodal MRI protocol
White matter hyperintensity burden will be computed as the total sum of the voxels segmented as hyperintensities multiplied by voxel dimensions to yield a total score (units of mm-cubed).
Hippocampal volume
Time frame: Derived from one acquisition sequence within a 50 min multimodal MRI protocol
Total bilateral hippocampal volume will be computed as the total sum of voxels automatically segmented.
Perivascular space volume
Time frame: Derived from one acquisition sequence in a 50 min multimodal MRI protocol
Total perivascular space volume will be computed from segmented brain blood vessel-tissue interfaces.
Pulse wave velocity
Time frame: 5 minutes
Pulse wave velocity in m/s will be assessed by dual impedance cardiography as a non-invasive indicator of arterial stiffness. This measure will be derived from the 5 minute baseline period.
Spontaneous baroreflex sensitivity
Time frame: 5 minutes
Spontaneous baroreflex sensitivity in ms/mmHg will be computed by the sequence method applied to beat-to-beat blood pressure and electrocardiogram recordings.
Endothelial function
Time frame: 15 minutes
Endothelial-dependent vasodilation will be measured non-invasively in a reactive hyperemia protocol using digital thermal monitoring.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Able to attend 2 study visits at the University of Pittsburgh campus in Oakland (Pennsylvania)
- Able to read and speak English
Exclusion criteria
- Uncontrolled hypertension (systolic blood pressure \>160 or diastolic blood pressure \>100 mmHg)
- Current use of anticonvulsant, anti-Parkinson, neuroleptic, or antipsychotic medications
- Current use of glucocorticoids (e.g., oral prednisone) or ephedrine
- Current chronic conditions of the lungs, liver and kidney, as well as cancer (chemotherapy and radiation) treatment in the past 12 months (allowances are made for non-melanoma skin cancer treatment, controlled asthma, and allergy inhalers)
- Self-reported major neurological disorders or brain injuries (e.g., multiple sclerosis, cerebral palsy, major head injury)
- Self-reported psychotic illnesses (mania, bipolar disorder, schizophrenia)
- Current pregnancy or childbirth within the past 6 months
- Suspected mild cognitive impairment or dementia
- Self reported sleep apnea
- Self-reported history of myocardial infarction, stroke, or revascularization procedures, as well as treatment for cardiac arrhythmias
- Self-reported lack of comfort to undergo MRI testing
- Presence of implants or objects that are unsafe for MRI (e.g., tattooed eyeliner), as well as any other contraindications that would prevent MRI testing
- Self-reported lack of comfort to undergo the laboratory math task
Where
- Pittsburgh, Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 26, 2025 · Source of record for eligibility and locations