Q-Collar effects on brain blood flow during rest and exercise
Evaluating Q-Collar Effects on Cerebrovascular Control in Response to Exercise
NA · Spaulding Rehabilitation Hospital · NCT06826781
This trial will test whether wearing the Q-Collar changes brain blood flow control during rest and exercise in healthy adults aged 18–30.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital (other) |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT06826781 on ClinicalTrials.gov |
What this trial studies
Healthy adults complete two lab visits 1–4 weeks apart during which they perform standing maneuvers, a resistive breathing task, and a graded stationary-bike exercise while heart rate, breathing gases, blood pressure, and cerebral blood flow are continuously monitored. Each participant is randomly assigned to wear the FDA-cleared Q-Collar during one visit and not wear it during the other, with identical tests performed at both sessions. Researchers compare cerebrovascular responses to sudden blood pressure changes and to exercise between the Q-Collar and no-collar conditions to see if the device alters blood flow regulation. Sessions include repeated standing tests, a controlled breathing challenge, and an incremental bike protocol with ratings of perceived exertion.
Who should consider this trial
Good fit: Healthy adults aged 18 to 30 without recent concussion, neurologic disorders, pregnancy, high cardiac risk, or ongoing cardioactive medication use are eligible.
Not a fit: People with concussion or other brain injury within the past 24 months, neurologic disease, pregnancy, high cardiac risk, current cardioactive drug treatment, or those outside the age range are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the Q-Collar could improve cerebral blood flow regulation during sudden blood pressure changes and exercise, which might help reduce brain strain in activities with rapid head or pressure changes.
How similar studies have performed: Some prior work has examined the Q-Collar for brain protection in athletic settings, but its effects on cerebrovascular regulation during exercise remain not well established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * healthy individuals between the ages of 18 to 30 years old Exclusion Criteria: * History of concussion or other brain injury resulting in loss or alteration in consciousness or other change in cognition within 24 months of study visit * High cardiac risk according to the American College of Sports Medicine (ACSM)11 * Ongoing active treatment with a cardioactive drug * Inability to stand from a seated position unassisted * History of a neurologic disorder or neurosurgery intervention * Pregnancy * Any current, serious, chronic medical or psychiatric disease that in the Principal Investigator's or co-investigator's judgment may interfere with study participation or data integrity * Unable or unwilling to provide informed consent
Where this trial is running
Cambridge, Massachusetts
- Spaulding Rehabilitation Hospital — Cambridge, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: J. Andrew Taylor, MS, PhD — Harvard Medical School/Spaulding Rehabilitation Hospital
- Study coordinator: J. Andrew Taylor, MS, PhD
- Email: jandrew_taylor@hms.harvard.edu
- Phone: 617-758-5503
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: Healthy, Q-Collar, Cerebrovascular Blood Flow Regulation, Exercise