Clinical trial NCT06542419: Brain Cooling Biomarkers
Official title: The Effect of Selective Brain Cooling on Electrophysiological and Neuroinflammatory Biomarkers of Cognition and Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health
Neurological Health
Keywords: Electroencephalography (EEG)
Brain cooling
Neuroinflammation
Cytokines
Mental health
Depression
Anxiety
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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, while the control group will not. All other environmental, timing, and testing measures will remain constant between the groups as indicated in the study description.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 18-24 years old.

Exclusion Criteria:

* Not currently recovering from neurological injury or illness.

Primary outcomes:
measure: Trail Making Test
timeFrame: 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).
measure: Digit Span Test
timeFrame: 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).
measure: Beck's Depression Inventory-Fast Screen
timeFrame: 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).
measure: HAM-A
timeFrame: 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).
measure: Digit Symbol Test
timeFrame: 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).
measure: Neuroinflammatory Cytokines
timeFrame: 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).
measure: The Penn State Worry Questionnaire
timeFrame: 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).
measure: EEG Pattern
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Recreation Building
state: Pennsylvania
Study officials:
References:
citation: 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.
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citation: 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.