The Association Between Head Cooling and Cognition, Neuroinflammatory Cytokines, Menstrual Cycle, Sleep Patterns, Mental Health and Concussions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Penn State University
- Enrollment
- 32
- Locations
- 2
- Primary Endpoint
- Beck's Depression Inventory-Fast Screen
Study Overview
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.
Detailed Description
Concussions are a form of mild traumatic brain injury (mTBI) that can lead to prolonged physical, cognitive, emotional, neuroinflammatory symptoms. An increase in IL-6 levels is seen due to neuroinflammation following mTBI. Following a concussion, females are more likely to experience sleep disturbances. This can impact the number of headaches and mood changes they experience. Emerging evidence suggests that hormonal fluctuations across the menstrual cycle may influence concussion recovery and symptoms specifically in the luteal phase.
Head cooling, or localized cranial hypothermia, has been explored as a therapeutic intervention to reduce neuroinflammation and cerebral metabolic demands following brain injury. Head cooling has been shown to reduce post-concussion symptoms recovery time and lessen the severity of symptoms like sleep disruptions, mood changes, and cognitive dysfunctions as well as decrease intracranial pressure. Recent research from our lab has also demonstrated that selective head cooling decreases depression symptoms and increases alpha wave power (measured via EEG). The gap that exists in the research is the effect that head cooling could have to help mitigate concussion symptoms specifically during the luteal phase of the menstrual cycle.
Thirty-two females, aged 18-27, will participate in this study (N=16 with acute concussion, N=16 healthy controls). Both sample groups will be randomly separated into placebo and head cooling intervention groups. The study will last the length of one pre-standardized menstrual cycle (28 days). The intervention group will receive 30-minute head cooling treatment, 5 days per week (Monday-Friday), while the placebo group will be instructed to continue normal daily activities without intervention. Participants will be asked to provide a blood sample on Day 1 and Day 28, which will be analyzed for serum concentration of Interluken-6 (IL-6), a neuroinflammatory biomarker. Also, on Day 1 and Day 28, participants will complete a brief cognitive testing battery that includes: the Psychomotor Vigilance Task (PVT), the Dual 2-Back, and the Stroop Task; as well as a brief psychological battery that includes: Beck's Depression Inventory-Fast Screen (BDI-fs), Hamilton Anxiety Rating Scale (HAM-A), and the Penn State Worry Questionnaire (PSWQ). Over the 28-day study timeline, participants will be asked to record their daily sleep using the free app, Consensus Sleep Diary (CSD) and record their daily menstrual cycle and symptoms using the free app, Clue, and record their daily concussion symptoms using a de-identified Qualtrics survey format Post-Concussion Symptom Scale (PCSS).
Visit 1 will occur on Day 1 of the study. Participants will be instructed to refrain from food, water, or brushing teeth for at least 30 minutes prior to their visit. At this time, the participants will be randomly assigned to the control or intervention group.
Participants will be asked to provide a blood sample, drawn by a registered nurse. This method requires the participants to have 5.0 mL of blood drawn. Samples will then be immediately stored in a marked freezer unit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 27 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Beck's Depression Inventory-Fast Screen
Time Frame: The metrics will be assessed on pre-intervention (Day 1) and post-intervention (Day 28).
The Beck's Depression Inventory-Fast Screen is a 13-item subjective report of depression symptoms.
HAM-A
Time Frame: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
the HAM-A is a 14-item subjective report of anxiety symptoms.
The Penn State Worry Questionnaire
Time Frame: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
The Penn State Worry Questionnaire is a 16-item subjective report of perceived worry.
Psychomotor Vigilance Task (PVT)
Time Frame: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
The PVT is a very brief (\<1 min) test to assess reaction time and sustained attention.
Dual 2-back Test
Time Frame: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
The Dual 2-back Test is a 72 second measure of working memory.
Stroop Task
Time Frame: The metrics will be assessed pre-intervention (Day 1) and post-intervention (Day 28).
The Stroop task is a brief measure of selective attention, processing speed, and executive function
Secondary Outcomes
- 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).)
Investigators
Owen Griffith
Assistant Teaching Professor of Kinesiology
Penn State University