Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06390267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-04-17
Brief Title:
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
Sponsor:
Spark Biomedical Inc
Organization:
Spark Biomedical Inc
Study Overview
Official Title:
Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASR
Brief Summary:
The objective of this study is to test the effects of transcutaneous auricular neurostimulation tAN in treating or preventing performance degradation after an acute stressor
Detailed Description:
This study is designed as a randomized double-blind sham-controlled trial Sixty healthy able-bodied participants will be randomized 1122 into one of four experimental groups
Group 1 Active tAN for prophylactic treatment prior to acute stress exposure N10
Group 2 Sham stimulation for prophylactic treatment prior to acute stress exposure N10
Group 3 Active tAN for acute treatment during acute stress exposure N20
Group 4 Sham stimulation for acute treatment during acute stress exposure N20
Participants will complete a baseline performance of three tasks tAN treatment will then be administered prior to or during an acute stress test Participants will complete the same three tasks preformed at baseline In addition to the tAN therapy earpiece subjects will have biosensors attached to them to collect biomarker information
Group 1 Active tAN for prophylactic treatment prior to acute stress exposure N10
Group 2 Sham stimulation for prophylactic treatment prior to acute stress exposure N10
Group 3 Active tAN for acute treatment during acute stress exposure N20
Group 4 Sham stimulation for acute treatment during acute stress exposure N20
Participants will complete a baseline performance of three tasks tAN treatment will then be administered prior to or during an acute stress test Participants will complete the same three tasks preformed at baseline In addition to the tAN therapy earpiece subjects will have biosensors attached to them to collect biomarker information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None