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Completed

NCT Number: NCT06542419

Brain Cooling Biomarkers

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.

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Key information

Conditions

Mental Health Anxiety Disorders Behavior Behavioral Symptoms Depression Inflammation Mental Disorders Nervous System Diseases Neuroinflammatory Diseases Neurological Health Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recreation Building

University Park, Pennsylvania, 16802, United States

About this study

This research attempts to address gaps in the current literature about the effect of selective brain cooling (SBC) on cognition, mood, electrophysiological markers of brain health and neuroinflammation in healthy subjects. In this study, the investigators will examine the short-term effect of one session of 30 minutes of brain cooling is on EEG patterns, neuroinflammation, cognition, and mood. The investigators will also examine the effect of a week-long intervention of 30 minutes of brain cooling per day on EEG patterns, neuroinflammation, cognition, mood. The overarching goal of this study is to validate the inclusion of selective brain cooling as an easy and safe addition to general health and clinical practice dedicated to cognitive and mood related neuropsychological health.

A minimum of 24 participants will be recruited for this study. 8 days of consecutive visits will be scheduled based on participant availability. Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, while listening to calming natural sounds, during which the participants will wear an 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 in a wakeful state to the best of their ability. Participants assigned to the control group will be instructed similarly, but the brain cooling cap will not be functional.

The trial will consist of a 1-week daily intervention period and three major measurement time points: pre-intervention on Day 1, conclusion of Day 1, and post-intervention on Day 8. Day 1 will last approximately 105 minutes and will consist of 6 parts: completion of study consent form (10 min), saliva swab (5 min), administration of questionnaires and cognitive tests (10 min), electroencephalography (EEG) (20 mins), brain cooling or seated rest (30 mins), repeat questionnaires (10 mins), and repeat EEG (20 mins). The intervention period will consist of 7 days of daily administration of either 30 minutes of brain cooling or 30 minutes of seated rest. Day 8 will last approximately 35 minutes and will consist of: saliva swab (5 min), administration of questionnaires (10 min), electroencephalography (EEG) (20 mins).

Questionnaires administered to the participants at T1 and T2 will include: Penn State Worry Questionnaire (PSWQ), Hamilton Anxiety Rating Scale (HAM-A), Beck's Depression Inventory-Fast Screen (BDI-FS), Digit Span Test, Digit Symbol Test, Trail Making Test. All questionnaires and tests will be administered verbally or with paper and pencil.

Cheek swabs will be taken after the completion of the initial questionnaires. The process is as follows: for each subject the tester will use 10 swabs. Five swabs will be used to rub inside the left part of the mouth, and the other five will be used to rub inside the right part of the mouth. The exact area that will be swabbed will include the inside of the cheek, lip, and gums. This will be completed with a little pressure against the mouth and turning the swab slightly during the process. This will last approximately 20 seconds per swab. This cheek swab will allow us to test for levels of neuroinflammatory enzymes present in saliva.

EEG will be administered using a 19-channel EEG cap and analyzed using Neuroguide V2.8. Participants will be asked to maintain a seated position, while the EEG cap is fitted and proper electroconductance of all 19 electrodes is established with the scalp. This is done by injecting electroconduction gel through opening in each electrode using a blunt needle. Next, electrophysiological signal is recorded from the electrode cap for a 3-minute period. EEG in non-invasive and very minimal risk to the participant, with the exception of slight discomfort from adjustments to the cap on sensitive scalps or maintenance of the seated position for up to 20 minutes.

Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, while listening to calming natural sounds, during which participants will wear an 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. Participants assigned to the control group will be instructed similarly, with the exclusion having the cooling cap turned on.

Directly following either the brain cooling or rest period, neuropsychological tests and questionnaires and EEG administration will be repeated prior to the subject leaving.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-24 years old.

Exclusion criteria

  • Not currently recovering from neurological injury or illness.

Treatment and study plan

Brain Cooling

Device

Brain cooling consists of a 30-minute seated period, in a dimly lit, quiet room, while listening to calming natural sounds, during which they will wear an 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 on 7 consecutive days.

Other names: Selective brain cooling, Cooling cap

Primary outcomes

  1. Trail Making Test

    Time frame: 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 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.

  2. Digit Span Test

    Time frame: 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 Digit Span test ask participants to repeat strings of digits in either normal or reverse order to test cognition and working memory.

  3. Beck's Depression Inventory-Fast Screen

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

  4. HAM-A

    Time frame: 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 HAM-A is a 14-item subjective report of anxiety symptoms.

  5. Digit Symbol Test

    Time frame: 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 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.

  6. Neuroinflammatory Cytokines

    Time frame: 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).

    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.

  7. The Penn State Worry Questionnaire

    Time frame: 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 is a 16-item subjective report of perceived worry.

  8. EEG Pattern

    Time frame: 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 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.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

The Effect of Selective Brain Cooling on Electrophysiological and Neuroinflammatory Biomarkers of Cognition and Mood

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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