Mental HealthNCT06542419
Brain Cooling Biomarkers
A study testing Brain Cooling in people with Mental Health and Neurological Health, run by Penn State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Neurological Health
- What is being tested?
- Brain Cooling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24 years old.
Who cannot join
- Not currently recovering from neurological injury or illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Recreation Building
University Park, Pennsylvania, 16802
About this study
Official title: The Effect of Selective Brain Cooling on Electrophysiological and Neuroinflammatory Biomarkers of Cognition and Mood
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.
Read the 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.
- Conditions
- Mental Health, Neurological Health
- Being tested
- Brain Cooling
- Keywords
- Electroencephalography (EEG), Brain cooling, Neuroinflammation, Cytokines, Mental health, Depression, Anxiety
- Medical subject headings
- Psychological Well-Being, Neuroinflammatory Diseases, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain CoolingDevice
Also called Selective brain cooling, Cooling cap
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start19 Aug 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semyon M. Slobounov, Ph.D., Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542419
- Sponsor's protocol ID
- Brain Cooling Biomarkers
- Status last verified
- Aug 2024
- First submitted
- 5 Aug 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28712093Tan 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.
PubMed 37678507Westermaier 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.
PubMed 28038481Leung 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.
PubMed 30123177Deng 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.
PubMed 12970518undefined
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.
PubMed 34009790
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Selective Brain Cooling on Electrophysiological and Neuroinflammatory Biomarkers of Cognition and Mood
- ClinicalTrials.gov ID
- NCT06542419
- Acronym / sponsor ID
- Brain Cooling Biomarkers
- Conditions
- Mental Health, Neurological Health
- Keywords
- Electroencephalography (EEG), Brain cooling, Neuroinflammation, Cytokines, Mental health, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Brain Cooling Treatment | Experimental | Device: Brain CoolingBrain 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. |
| 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. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-24 years old.
Key exclusion criteria (1 listed)
- Not currently recovering from neurological injury or illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain CoolingAlso: Selective brain cooling, Cooling capBrain 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 Treatment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 28712093Walter 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.
- Background: PubMed 37678507Tan 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.
- Background: PubMed 28038481Westermaier 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.
- Background: PubMed 30123177Leung 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.
- Background: PubMed 12970518Deng 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.
- Backgroundundefined
- Background: PubMed 34009790Congeni 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.
- publication from the Journal of Cerebral Blood Flow Metabolism describing use of this product in the methodsLink provided by the sponsor.
- Aspen Cooling Systems (product designer)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Cooling in people with Mental Health and Neurological Health, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542419, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.