Brain Cooling Biomarkers

NCT06542419 | Completed

• 1 other identifier: Brain Cooling Biomarkers
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health; Neurological Health

Keywords

Electroencephalography (EEG); Brain cooling; Neuroinflammation; Cytokines; Mental health; Depression; Anxiety

Outcome Measures

Primary Outcomes (8)

• 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).

Study Arms (2)

Brain Cooling Treatment

EXPERIMENTAL

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.

Device: Brain Cooling

Control

NO INTERVENTION

The control arm consists of a 30-minute seated period, in a dimly lit, quiet room, while listening to calming natural sounds. Participants will be asked to remain awake, refrain from observing a screen, and relax to the best of their ability.

Interventions

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.

Also known as: Selective brain cooling, Cooling cap

Brain Cooling Treatment

Eligibility Criteria

• Age: 18 Years - 24 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old.

You may not qualify if:

• Not currently recovering from neurological injury or illness.

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Recreation Building

University Park, Pennsylvania, 16802, United States

Location

Related Publications (7)

• 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.

  PMID: 28712093 BACKGROUND

• Tan XR, Stephenson MC, Alhadad SB, Loh KWZ, Soong TW, Lee JKW, Low ICC. Elevated brain temperature under severe heat exposure impairs cortical motor activity and executive function. J Sport Health Sci. 2024 Mar;13(2):233-244. doi: 10.1016/j.jshs.2023.09.001. Epub 2023 Sep 9.

  PMID: 37678507 BACKGROUND

• Westermaier T, Nickl R, Koehler S, Fricke P, Stetter C, Rueckriegel SM, Ernestus RI. Selective Brain Cooling after Traumatic Brain Injury: Effects of Three Different Cooling Methods-Case Report. J Neurol Surg A Cent Eur Neurosurg. 2017 Jul;78(4):397-402. doi: 10.1055/s-0036-1596057. Epub 2016 Dec 30.

  PMID: 28038481 BACKGROUND

• Leung LY, Cardiff K, Yang X, Srambical Wilfred B, Gilsdorf J, Shear D. Selective Brain Cooling Reduces Motor Deficits Induced by Combined Traumatic Brain Injury, Hypoxemia and Hemorrhagic Shock. Front Neurol. 2018 Aug 3;9:612. doi: 10.3389/fneur.2018.00612. eCollection 2018.

  PMID: 30123177 BACKGROUND

• Deng H, Han HS, Cheng D, Sun GH, Yenari MA. Mild hypothermia inhibits inflammation after experimental stroke and brain inflammation. Stroke. 2003 Oct;34(10):2495-501. doi: 10.1161/01.STR.0000091269.67384.E7. Epub 2003 Sep 11.

  PMID: 12970518 BACKGROUND

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  BACKGROUND

• 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.

  PMID: 34009790 BACKGROUND

Related Links

• publication from the Journal of Cerebral Blood Flow Metabolism describing use of this product in the methods
• Aspen Cooling Systems (product designer)

MeSH Terms

Conditions

Psychological Well-Being; Neuroinflammatory Diseases; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 7, 2024
• Study Start: August 19, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: May 1, 2025

Record last verified: 2024-08

Locations

US (1)