Female Concussion Head Cooling

NCT07303933 | Not Yet Recruiting FDA Device

• 1 other identifier: Female Concussion Head Cooling
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Brain cooling; Concussion; Neuroinflammation; Mental Health; Cognition; Menstrual cycle; Female

Outcome Measures

Primary Outcomes (6)

• Beck's Depression Inventory-Fast Screen

  The Beck's Depression Inventory-Fast Screen is a 13-item subjective report of depression symptoms.

  The metrics will be assessed on pre-intervention (Day 1) and post-intervention (Day 28).

• HAM-A

  the HAM-A is a 14-item subjective report of anxiety symptoms.

  The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).

• The Penn State Worry Questionnaire

  The Penn State Worry Questionnaire is a 16-item subjective report of perceived worry.

  The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).

• Psychomotor Vigilance Task (PVT)

  The PVT is a very brief (\<1 min) test to assess reaction time and sustained attention.

  The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).

• Dual 2-back Test

  The Dual 2-back Test is a 72 second measure of working memory.

  The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).

• Stroop Task

  The Stroop task is a brief measure of selective attention, processing speed, and executive function

  The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).

Secondary Outcomes (3)

• Consensus Sleep Diary (CSD)

  CSD will be recorded daily throughout the intervention (from Day 1 to Day 28).

• Clue App

  Clue entries will be recorded daily throughout the intervention (from Day 1 to Day 28).

• Post-Concussion Symptom Scale (PCSS)

  PCSS will be recorded daily throughout the intervention (from Day 1 to Day 28).

Study Arms (2)

Brain Cooling Treatment

EXPERIMENTAL

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.

Device: Brain Cooling

Control

NO INTERVENTION

Control participants will maintain their normally prescribed concussion recovery protocol as outlined by their outside clinicians.

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.

Brain Cooling Treatment

Eligibility Criteria

• Age: 18 Years - 27 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Exclude smokers and former smokers, as defined by CDC. (Anyone who smokes daily or who has smoked at least 100 cigarettes in their lifetime)
• Those with scalp infections, sun burns, skin cancers, and/or prior surgical scars should not participate
• Those with presence of an active infection (including a dental infection)
• Exclude persons who have migraines
• Exclude persons taking mood stabilizer medications
• Exclude persons who have consumed alcohol within 48 hours prior to study participation.
• Exclude persons who are males

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Recreation Building

University Park, Pennsylvania, 16802, United States

Location

Related Publications (6)

• Congeni J, Murray T, Kline P, Bouhenni R, Morgan D, Liebig C, Lesak A, McNinch NL. Preliminary Safety and Efficacy of Head and Neck Cooling Therapy After Concussion in Adolescent Athletes: A Randomized Pilot Trial. Clin J Sport Med. 2022 Jul 1;32(4):341-347. doi: 10.1097/JSM.0000000000000916. Epub 2021 Mar 10.

  PMID: 34009790 BACKGROUND

• Deng H, Han HS, Cheng D, Sun GH, Yenari MA. Mild hypothermia inhibits inflammation after experimental stroke and brain inflammation. Stroke. 2003 Oct;34(10):2495-501. doi: 10.1161/01.STR.0000091269.67384.E7. Epub 2003 Sep 11.

  PMID: 12970518 BACKGROUND

• Leung LY, Cardiff K, Yang X, Srambical Wilfred B, Gilsdorf J, Shear D. Selective Brain Cooling Reduces Motor Deficits Induced by Combined Traumatic Brain Injury, Hypoxemia and Hemorrhagic Shock. Front Neurol. 2018 Aug 3;9:612. doi: 10.3389/fneur.2018.00612. eCollection 2018.

  PMID: 30123177 BACKGROUND

• Westermaier T, Nickl R, Koehler S, Fricke P, Stetter C, Rueckriegel SM, Ernestus RI. Selective Brain Cooling after Traumatic Brain Injury: Effects of Three Different Cooling Methods-Case Report. J Neurol Surg A Cent Eur Neurosurg. 2017 Jul;78(4):397-402. doi: 10.1055/s-0036-1596057. Epub 2016 Dec 30.

  PMID: 28038481 BACKGROUND

• Tan XR, Stephenson MC, Alhadad SB, Loh KWZ, Soong TW, Lee JKW, Low ICC. Elevated brain temperature under severe heat exposure impairs cortical motor activity and executive function. J Sport Health Sci. 2024 Mar;13(2):233-244. doi: 10.1016/j.jshs.2023.09.001. Epub 2023 Sep 9.

  PMID: 37678507 BACKGROUND

• Walter A, Finelli K, Bai X, Johnson B, Neuberger T, Seidenberg P, Bream T, Hallett M, Slobounov S. Neurobiological effect of selective brain cooling after concussive injury. Brain Imaging Behav. 2018 Jun;12(3):891-900. doi: 10.1007/s11682-017-9755-2.

  PMID: 28712093 BACKGROUND

Related Links

• publication from the Journal of Cerebral Blood Flow Metabolism describing use of this product in the methods

MeSH Terms

Conditions

Brain Concussion; Disease; Post-Concussion Syndrome; Neuroinflammatory Diseases; Psychological Well-Being

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Personal Satisfaction; Behavior

Central Study Contacts

Owen Griffith, PhD

CONTACT

15709858794; omg5007@psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Teaching Professor of Kinesiology

Model Details: This will be a straight forward parallel intervention model. Even numbers of participants will be randomly assigned to the treatment or control arms. The treatment group will receive the brain cooling intervention during their visits (on top of normal clinical care), while the control group will receive their normal clinical care. All other environmental, timing, and testing measures will remain constant between the groups as indicated in the study description.

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: December 26, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

US (1)