Female Concussion Head Cooling
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-27
SponsorPenn State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Brain Cooling
DeviceBrain 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.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Brain Cooling TreatmentExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Beck's Depression Inventory-Fast Screen
The Beck's Depression Inventory-Fast Screen is a 13-item subjective report of depression symptoms.
Time frame
The metrics will be assessed on pre-intervention (Day 1) and post-intervention (Day 28).2
HAM-A
the HAM-A is a 14-item subjective report of anxiety symptoms.
Time frame
The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).3
The Penn State Worry Questionnaire
The Penn State Worry Questionnaire is a 16-item subjective report of perceived worry.
Time frame
The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).4
Psychomotor Vigilance Task (PVT)
The PVT is a very brief (\<1 min) test to assess reaction time and sustained attention.
Time frame
The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).Secondary outcomes
1
Consensus Sleep Diary (CSD)
The CSD is a remote application that allows for description and tracking of metrics related to sleep quantity and quality.
Time frame
CSD will be recorded daily throughout the intervention (from Day 1 to Day 28).2
Clue App
The Clue App is a qualitative journaling tool for recording menstrual cycle timeline and symptom severity.
Time frame
Clue entries will be recorded daily throughout the intervention (from Day 1 to Day 28).3
Post-Concussion Symptom Scale (PCSS)
The PCSS is a 21 item concussion symptom self-scoring measure. Each item ranks a different concussion symptom category on a 0-6 scale.
Time frame
PCSS will be recorded daily throughout the intervention (from Day 1 to Day 28).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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