Q-Collar for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore how the Q-Collar, a device cleared by the FDA, affects brain blood flow in healthy adults during rest and exercise. Researchers seek to determine if the collar can improve blood flow during rapid changes in blood pressure, such as standing up quickly, or during breathing and exercise tasks. Participants will compare their brain blood flow with and without the Q-Collar to assess its impact. Ideal candidates are healthy individuals who can stand unassisted and have no recent history of brain injuries. As an unphased trial, this study offers participants the opportunity to contribute to innovative research on enhancing brain health and blood flow.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on ongoing active treatment with a cardioactive drug (medication affecting heart function).
What prior data suggests that the Q-Collar device is safe for healthy adults?
Research has shown that the Q-Collar is safe for use. Studies have found no harmful effects, indicating it is well-tolerated. The Q-Collar gently presses on the neck without blocking blood flow through vital arteries, such as the carotid arteries, which supply blood to the brain. Additionally, the FDA has approved the Q-Collar, confirming it meets safety standards for its intended use.12345
Why are researchers excited about this trial?
Researchers are excited about the Q30 Q-Collar because it offers a novel approach to managing cerebrovascular responses. Unlike traditional methods that might involve medications to regulate blood pressure or protect the brain, the Q-Collar is a non-invasive device designed to be worn around the neck. It works by applying gentle pressure to the jugular vein, potentially increasing blood flow to the brain and stabilizing blood pressure during rapid changes in body position. This unique mechanism of action could provide a simple and immediate way to support brain health, particularly during physical activities.
What evidence suggests that the Q-Collar is effective for improving brain blood flow?
Research shows that the Q-Collar is designed to help protect the brain by keeping it stable during impacts, without affecting blood flow through the main arteries in the neck. However, studies have not proven that the Q-Collar can prevent concussions or serious brain injuries. In this trial, participants in the "Cerebrovascular Control with Q-Collar" arm will undergo measurements of cerebral blood flow while wearing the Q-Collar to evaluate its effects on cerebrovascular responses. Some research indicates that the device does not change blood pressure or the speed of blood flow in the brain when standing. While the FDA has approved the Q-Collar for certain uses, its effects on long-term brain health remain not fully understood.13467
Who Is on the Research Team?
J. Andrew Taylor, MS, PhD
Principal Investigator
Harvard Medical School/Spaulding Rehabilitation Hospital
Are You a Good Fit for This Trial?
This trial is for healthy adults interested in how a device called the Q-Collar might influence brain blood flow during rest and exercise. Participants will be asked to do physical tasks like standing tests, breathing tests, and cycling. They must be available for two study visits spaced 1 to 4 weeks apart.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete two study visits, performing standing, breathing, and exercise tests with and without the Q-Collar
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Q30 Q-Collar
Find a Clinic Near You
Who Is Running the Clinical Trial?
Spaulding Rehabilitation Hospital
Lead Sponsor