Female Concussion Head Cooling

Part of paid clinical trials in University Park, Pennsylvania.

Sponsor
Penn State University
Study ID
NCT07303933
Status
Not Yet Recruiting

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Conditions

  • Concussion (Diagnosis)
  • Concussion Post Syndrome
  • Concussion, Mild

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 27 Years
Healthy Volunteers
Not accepted

Interventions

  • Brain Cooling — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 15, 2026
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brain Cooling Treatment
    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.
  • No Intervention: Control
    Control participants will maintain their normally prescribed concussion recovery protocol as outlined by their outside clinicians.

Primary Outcome Measure

Beck's Depression Inventory-Fast Screen [ Time Frame: The metrics will be assessed on pre-intervention (Day 1) and post-intervention (Day 28). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Recreation BuildingUniversity ParkPennsylvania16802
Owen M Griffith, PhD
[email protected]
5709858794

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By research site
Recreation Building· University Park, PA

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