Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542419
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Brain Cooling Biomarkers
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Selective Brain Cooling on Electrophysiological and Neuroinflammatory Biomarkers of Cognition and Mood
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 V130 set at a temperature of 330 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 Becks 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 V28 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 V130 set at a temperature of 330 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
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 V130 set at a temperature of 330 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 Becks 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 V28 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 V130 set at a temperature of 330 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None