Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan (NCT06127667) | Clinical Trial Compass
RecruitingNot Applicable
Brain Vascular and Neural Function Linked to Balance Across the Adult Lifespan
United States102 participantsStarted 2024-10-15
Plain-language summary
This is a single-arm, two-visit, non-randomized, cross sectional study identified as an intervention due to the use of a single bout of aerobic exercise to assess cerebrovascular function under the NIH rules. This study is not masked and its primary purpose is to develop a basic science understanding of the relationship between cerebrovascular health and balance control with aging. This study will involve 102 individuals classified as younger adults, middle-aged adults, and older adults who are neurotypical and cognitively normal. The primary outcome from a clinical trials perspective will be cerebrovascular response to a bout of aerobic exercise (i.e. change in cerebral blood flow with the performance of aerobic exercise on a recumbent stepper exercise machine). Non-interventional outcomes will be EEG measures of cortical activity and biomechanical kinetic and kinematic data recorded during standing balance reactions, as well as biological blood samples for genomic analysis.
Who can participate
Age range
21 Years – 95 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:
* Age within the following 3 group age ranges, 21-30yo; middle-aged: 40-55yo; older: 65-95yo adults
* the absence of major orthopedic disability
* cognitively normal (MoCA score ≥ 26/30 in older adult group)
* vision that is 20/40 or better with or without corrective lenses, (5) the ability to consent and communicate with researchers
* English speaking
* ability to stand for 3 minutes and walk 10 meters with or without an assistive device and without the assistance of another person.
Exclusion Criteria:
* insulin-dependent diabetes
* peripheral neuropathy
* myocardial infarction or symptoms of coronary artery disease within 2 years
* congestive heart failure or class IV heart failure
* any significant sensory impairment affecting balance or cognition; visual, vestibular, or auditory impairments.
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
cerebral blood flow velocity assessed using transcranial Doppler ultrasound
Timeframe: 1 week
2
Kinetic center of pressure rate of rise post-balance perturbation, assessed biomechanically.
Timeframe: 1 week
3
Prefrontal-M1 coherence an S1-M1 coherence post-balance perturbation, assessed using EEG