Clinical trial NCT06390267: Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
Official title: Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Stress Reaction
Cognitive Performance
Keywords: Healthy Human
Performance
Stress
Vagus Nerve Stimulation
Neurostimulation
Transcutaneous Auricular Neurostimulation
Military
Lead sponsor: Spark Biomedical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Battelle Memorial Institute
name: United States Department of Defense
First posted: 2024-04-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is designed as a randomized, double-blind, sham-controlled trial in sixty healthy, able-bodied participants. Participants will be randomized to one of four treatment groups in a 1:1:2:2 ratio. Twice as many participants will be randomized to the acute treatment active tAN and acute treatment sham tAN arms (Groups 3 and 4) compared to the prophylactic treatment group arms (Groups 1 and 2).
Primary purpose: TREATMENT

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 1:1:2:2 into one of four experimental groups:

Group 1: Active tAN for prophylactic treatment prior to acute stress exposure (N=10)

Group 2: Sham stimulation for prophylactic treatment prior to acute stress exposure (N=10)

Group 3: Active tAN for acute treatment during acute stress exposure (N=20)

Group 4: Sham stimulation for acute treatment during acute stress exposure (N=20)

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.

Eligibility criteria: Inclusion Criteria:

1. Adults 18 to 41 years old
2. Participant has the cognitive and physical abilities to carry out the study tasks
3. Proficient in the English language
4. Ability to understand the explanations and instructions given by the study personnel

Exclusion Criteria:

1. Participant presents current evidence of an uncontrolled and/or clinically significant medical condition or psychiatric condition
2. Participant has used any psychological stress-management intervention within the last 4 weeks
3. Participant is participating in another interventional trial within 90 days prior to or throughout duration of trial
4. Participant has a prior diagnosis of post-traumatic stress disorder, acute stress disorder, or generalized anxiety disorder
5. Participant is currently using anti-anxiety medications such as Xanax or beta blockers
6. Participant has a diagnosis of attention deficit hyperactivity disorder (ADHD) and/or is currently taking medications for the treatment of ADHD.
7. History of substance abuse or drug dependence including nicotine and alcohol in the past 3 months
8. Participant has abnormal ear anatomy, ear infection present, or earpiercing that could interfere with stimulation
9. Participant has a history of epileptic seizures
10. Participant has a history of neurologic diseases or traumatic brain injury
11. Participant wears or utilized other devices that cannot be removed during the study (e.g., pacemakers, cochlear prostheses, neurostimulators)
12. Females who are pregnant or lactating
13. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants are risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial

Primary outcomes:
measure: Match-to-Sample Task (MST)
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Psychomotor Vigilance Task (PVT)
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Perdue Pegboard Task (PPT)
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Maastricht Acute Stress Test (MAST)
timeFrame: After baseline tasks, approximately 35 minutes
Secondary outcomes:
measure: Mean change in performance on the MST in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Mean change in performance on the PVT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Mean change in performance on the PPT in the active tAN groups (Groups 1 and 3) compared to sham groups (Groups 2 and 4).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Mean change in performance on the MTS in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Mean change in performance on the PVT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Mean change in performance on the PPT in the prophylactic active tAN group (Group 1) compared to the acute active tAN group (Group 3).
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Change in working memory as measured by performance on the MST
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Change in reaction time as measured by performance on the PVT
timeFrame: From baseline to post-stressor (up to 3 hours)
measure: Change in dexterity as measured by performance on the PPT
timeFrame: From baseline to post-stressor (up to 3 hours)
Other outcomes:
measure: Change in heart rate variability in milliseconds (ms) across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in heart rate in beats per minute (bpm) across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in electrodermal activity across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in cortisol levels across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in Interleukin-6 (IL-6) levels across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in melatonin levels across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in Tumor Necrosis Factor Alpha (TNF-α) levels across groups
timeFrame: From baseline, during the stressor, and post-stressor (up to 3 hours)
measure: Change in self-reported stress across groups using the Stress Monitoring and Response Tool (SMART)
timeFrame: Before baseline to after post-stressor tasks (up to 3 hours; assessment valid up to 24 hours after event))
measure: Mean therapeutic stimulation intensity
timeFrame: From start to end of tAN (30 minutes)
Locations:
city: Columbus
country: United States
facility: Battelle Memorial Institute
state: Ohio
Study officials:
affiliation: Battelle Memorial Institute
name: Philip Putnam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Spark Biomedical, Inc.
name: Navid Khodaparast, PhD
role: PRINCIPAL_INVESTIGATOR
References: