Effect of Transcutaneous Auricular Neurostimulation on Cognitive Performance in a Laboratory Model of Acute Stress Reaction (ASR)

Spark Biomedical

Status: Completed

Conditions: Cognitive Performance; Acute Stress Reaction

Treatments: Device: Sparrow Hawk (Active); Device: Sparrow Hawk (Sham)

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT06390267

SBM-ASR-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18 to 41 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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43 participants in 4 patient groups

Active tAN for Prophylactic Treatment

Experimental group

Description:

Prophylactic Active participants will undergo 20 minutes of active tAN while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol.

Treatment:

Device: Sparrow Hawk (Active)

Sham Stimulation for Prophylactic Treatment

Sham Comparator group

Description:

Prophylactic Sham participants will undergo 20 minutes of sham stimulation while remaining seated and idle. After stimulation, participants will proceed into the 20-minute stressor protocol.

Treatment:

Device: Sparrow Hawk (Sham)

Active tAN for Acute Treatment

Experimental group

Description:

Acute Active participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, active tAN treatment will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol.

Treatment:

Device: Sparrow Hawk (Active)

Sham Stimulation for Acute Treatment

Sham Comparator group

Description:

Acute Sham participants will begin the stressor protocol immediately after baseline assessments. After a 5-min period of the stressor protocol without any intervention, sham stimulation will be delivered concurrently for the remainder of the stressor protocol for a total of 20 minutes of stimulation and approximately 25 minutes of the stressor protocol.

Treatment:

Device: Sparrow Hawk (Sham)