Brain Cooling Biomarkers
NCT Number: NCT06542419
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Mental Health|Neurological Health
Interventions: DEVICE: Brain Cooling
Sponsor: Penn State University
Sex: ALL
Age: ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-19
Completion Date: 2025-03-01

Summary:
This research is being done to examine the effects of brain cooling on cognition, electrophysiological brain activity via EEG scans, inflammation of the brain, and mood in healthy subjects. Brain cooling has been shown to cause temporary symptom relief after traumatic brain injury, but its implications for general brain and mental health remain unexplored.

Primary Outcome Measures: Trail Making Test, The Trail Making Test asks participants to trace a line connecting numbers and letters in logical order around a page. They are timed. It tests cognition and processing speed., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|Digit Span Test, The Digit Span test ask participants to repeat strings of digits in either normal or reverse order to test cognition and working memory., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|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 pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|HAM-A, the HAM-A is a 14-item subjective report of anxiety symptoms., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|Digit Symbol Test, The Digit Symbol Test is a 90 second test that requires subjects to continually match numbers 1-9 with corresponding symbols. This test measures processing speed, inhibition, and general cognition., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|Neuroinflammatory Cytokines, We will use the saliva acquired from cheek swabs to assess degree of circulating neuroinflammatory serum biomarkers. Specifically, we will examine the cytokines CRP and IL-6 which have been shown to be associated with neurological trauma and brain health., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|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 (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).|EEG Pattern, The investigators will use the data acquired from EEG to measure specific electrophysiological metrics (electrical field potential from brain activity). Specifically, we will isolate whole-brain relative alpha-power and relative beta-power., The metrics will be assessed pre-intervention (beginning of Day 1), after the acute effect of brain cooling (at the end of Day 1), and after the chronic effect of brain cooling (Day 8).