Female Concussion Head Cooling (NCT07303933) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Female Concussion Head Cooling
United States32 participantsStarted 2026-01-15
Plain-language summary
This research is being done to examine the benefits of a 28 day head cooling intervention on cognition, inflammation of the brain, sleep quality, menstrual symptom interaction, and mood in acutely concussed females. Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of full concussion recovery, particularly in females during periods of confounding neuropsychological menstrual symptoms, remains unexplored.
Who can participate
Age range
18 Years – 27 Years
Sex
FEMALE
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
. Require that any participant is 18-27 years old
. Require that participants be English speakers
. Require that participants are females
. Require that persons be able to provide consent for themselves
Exclusion criteria
. Exclude persons under 18 years old or over 27 years old
. Exclude persons taking anti-inflammatory drugs (both prescription and OTC), or those who will have taken them within 24 hours prior to Visit 1
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.
1This trial is specifically for females with concussion — given my diagnosis, does my situation fit what this study is looking for, and is it something worth discussing as an option?
2The trial uses head cooling as the intervention and measures things like depression, anxiety, worry, and cognitive tasks like reaction time and memory — based on my current symptoms, do you think those are the right outcomes to be focusing on for where I am in my recovery?
3Since this trial hasn't started recruiting yet, do you know roughly when it might open, and is it worth waiting for it or should we be moving forward with other treatment approaches now?
4The study is measuring cognitive performance using tasks like the Stroop Task and a dual memory test — are those kinds of difficulties something I'm actually experiencing enough for this to be relevant to my care?
5Are there established, standard treatments for post-concussion symptoms like anxiety and cognitive fog that I should be trying first before considering an experimental approach like head cooling?
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
Beck's Depression Inventory-Fast Screen
Timeframe: The metrics will be assessed on pre-intervention (Day 1) and post-intervention (Day 28).
2
HAM-A
Timeframe: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
3
The Penn State Worry Questionnaire
Timeframe: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
4
Psychomotor Vigilance Task (PVT)
Timeframe: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
5
Dual 2-back Test
Timeframe: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
6
Stroop Task
Timeframe: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).