Brain Cooling for Concussion
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cooling the head can alleviate symptoms after a concussion, focusing on women with symptoms related to their menstrual cycle. The main goal is to determine if this cooling can improve brain function, reduce brain inflammation, and enhance sleep and mood over four weeks. Participants will either wear a cooling cap (Head Cooling Intervention) for 30 minutes, five days a week, or follow their usual concussion recovery plan without the cooling cap. Ideal candidates for this trial are women who have recently experienced a concussion, are not on anti-inflammatory drugs or mood stabilizers, do not smoke, and do not suffer from migraines. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance concussion recovery strategies.
Will I have to stop taking my current medications?
If you are taking anti-inflammatory drugs or mood stabilizer medications, you will need to stop taking them to participate in this trial. You must not have taken anti-inflammatory drugs within 24 hours before the first visit.
What prior data suggests that this head cooling intervention is safe for concussed individuals?
Research shows that cooling the brain can temporarily ease symptoms after a head injury. Studies have found that cooling the head lowers brain temperature, which might help reduce damage and aid recovery. This method targets the injured area directly, potentially leading to fewer side effects than treatments affecting the whole body.
Other research found that cooling the head significantly lowered brain temperature in just 30 minutes, suggesting the treatment is well-tolerated and could be safe to use. While specific safety details for this trial aren't provided, existing evidence supports the safety of head cooling as a treatment.12345Why are researchers excited about this trial?
Researchers are excited about brain cooling for concussions because it offers a novel approach to recovery. Unlike standard treatments like rest and medication, this method uses a cooling cap to lower brain temperature, potentially reducing inflammation and speeding up healing. The treatment is non-invasive and integrates easily with existing concussion recovery protocols, providing a complementary option that could enhance overall recovery rates. This innovative method could pave the way for faster and more effective concussion management.
What evidence suggests that this head cooling intervention is effective for concussion recovery?
Research has shown that cooling the brain can ease symptoms after a head injury, such as a concussion. Studies have found that cooling the head aids faster recovery from sports-related concussions. For example, one study found that a cooling cap helped athletes return to sports more quickly. Another study with ice hockey players showed similar results, with players resuming play sooner after using head cooling. In this trial, participants in the Brain Cooling Treatment arm will undergo brain cooling sessions using the Welkins Arctic Cooling Cap. These findings suggest that brain cooling might speed up recovery for women with concussions, especially when symptoms are more severe.12467
Are You a Good Fit for This Trial?
This trial is for English-speaking females aged 18-27 who can provide consent for themselves. It's designed to help those with traumatic brain injury, including concussion and post-concussion syndrome, potentially affected by menstrual symptoms.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive head cooling treatment or continue normal activities for 28 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Head Cooling Intervention
Trial Overview
The study tests a head cooling intervention over a period of 28 days. Researchers want to see if it improves cognition, reduces brain inflammation, enhances sleep quality, affects menstrual symptoms interaction, and betters mood in concussed females.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, during which they will wear a Welkins Arctic Cooling Cap V1.30, set at a temperature of 33.0 degrees Fahrenheit. Participants will be asked to remain awake, refrain from observing a screen, and relax to the best of their ability. This brain cooling treatment will occur 5 days per week for 4 total weeks. Brain cooling treatment participants will also continue with their normally prescribed concussion recovery protocol as outlined by their outside clinicians.
Control participants will maintain their normally prescribed concussion recovery protocol as outlined by their outside clinicians.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Penn State University
Lead Sponsor
Citations
NCT07303933 | Female Concussion Head Cooling
Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of ...
Selective head–neck cooling after concussion shortens ...
We aimed to investigate whether selective head–neck cooling could shorten recovery after sports-related concussions (SRCs).
Brain Cooling for Concussion · Info for Participants
Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for decreasing timeline of ...
Science – Clinical Studies on Concussion Recovery
Clinical studies show PolarCap® improves concussion recovery, reducing long-term effects by up to 80% and helping athletes return to play faster.
Effects of Selective Head-and-Neck Cooling on Brain Injury ...
We hypothesized that acute head-and-neck cooling, recently shown to shorten return-to-play in concussed ice hockey players, applied acutely following a boxing ...
Systematic review of head cooling in adults after traumatic ...
Cooling therapy may reduce damage and potentially improve outcome. Head cooling targets the site of injury and may have fewer side effects than systemic cooling ...
Selective head cooling in the acute phase of concussive ...
MRS studies have shown that head cooling produced significant brain temperature reductions of 0.458° C after only 30 min (21) and decreases of ...
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