Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD

NCT ID: NCT06953388

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2032-12-31

Brief Summary

The goal of this study is to determine how non-invasive brain stimulation (delivered through the ear called vagus nerve stimulation) affects fear learning processes in people who have experienced psychological trauma. To answer these questions, we measure bodily responses (heart rate, sweat, startle) and questionnaires. The main questions it aims to answer are:

Does non-invasive vagus nerve stimulation help reduce anxious arousal? Does non-invasive vagus nerve stimulation help dampen learned fear?

Detailed Description

This study aims to determine how non-invasive brain stimulation (delivered through the ear) affects learning processes. During this study, participants who have experienced a trauma will be asked to complete surveys and come to the lab for about 7 hours across four lab visits. Researchers will measure body responses (heart rate, skin conductance, startle), while the ear is stimulated. Participants also will be asked to complete a startle task. The study is at the Wayne State University Tolan Park Research Clinic. Participants will be compensated for their time. To be eligible, participants must be 18-70 years old, have experienced or witnessed a traumatic event, be able to commit 7 hours of time to the study, and be able to wear sensors on their hands, arms, and head and sit quietly at a computer.

Aim 1. Establish feasibility and acceptability of taVNS in a diverse sample of Detroit metro residents with symptoms of posttraumatic stress. It is hypothesized that taVNS delivery will be feasible and acceptable for individuals with trauma exposure and PTS symptoms, and that there will be no difference in acceptability/tolerability between the active and sham conditions.

Aim 2. Establish the effects of active versus sham taVNS on physiological indicators during fear extinction. It is hypothesized that active compared to sham taVNS will a) result in facilitation of fear extinction, and b) show greater modulation of physiological responding. Exploratory Aim: Data will be explored for individual differences (affective blunting, hyperarousal, impaired discrimination of conditioned stimuli) which moderate taVNS effects.

This proposed project will determine how taVNS delivered at higher doses than have been previously administered influence the course of adaptive posttraumatic processing in a sample with trauma exposure, while evaluating the psychophysiological profile in multiple contexts.

Conditions

PTSD - Post Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Active taVNS

Active transcutaneous auricular vagus nerve stimulation

Group Type: EXPERIMENTAL

transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

FDA-cleared Digitimer DS7A Constant Current Stimulator (Digitimer Ltd., USA) will deliver electrical stimulation for 60 mins. Active stimulation will consist of direct electrical stimulation to the inner side of the left tragus (anode on the cymba concha, cathode on the surface of the tragus), thereby stimulating the ABVN. Stimulation parameters will consist of 500μs pulse width, 25Hz frequency, delivered at 200% of each participant's individual perceptual threshold (PT) in 60sec on/off trains.

Sham taVNS

Active transcutaneous auricular vagus nerve stimulation

Group Type: SHAM_COMPARATOR

sham transcutaneous auricular vagus nerve stimulation

Intervention Type: DEVICE

FDA-cleared Digitimer DS7A Constant Current Stimulator (Digitimer Ltd., USA) will deliver electrical stimulation for 60 mins. Sham will be delivered to the ear lobe. Stimulation parameters will consist of 500μs pulse width, 25Hz frequency, delivered at 200% of each participant's individual perceptual threshold (PT) in 60sec on/off trains.

Interventions

transcutaneous auricular vagus nerve stimulation

FDA-cleared Digitimer DS7A Constant Current Stimulator (Digitimer Ltd., USA) will deliver electrical stimulation for 60 mins. Active stimulation will consist of direct electrical stimulation to the inner side of the left tragus (anode on the cymba concha, cathode on the surface of the tragus), thereby stimulating the ABVN. Stimulation parameters will consist of 500μs pulse width, 25Hz frequency, delivered at 200% of each participant's individual perceptual threshold (PT) in 60sec on/off trains.

Intervention Type: DEVICE

sham transcutaneous auricular vagus nerve stimulation

FDA-cleared Digitimer DS7A Constant Current Stimulator (Digitimer Ltd., USA) will deliver electrical stimulation for 60 mins. Sham will be delivered to the ear lobe. Stimulation parameters will consist of 500μs pulse width, 25Hz frequency, delivered at 200% of each participant's individual perceptual threshold (PT) in 60sec on/off trains.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Ages 18-80

2. Fluent in English

3. Experience with a DSM-5 Criterion A trauma (LEC-5)

4. Probable PTSD (PCL-5 ≥ 32)

Exclusion Criteria

1. Visual or Auditory impairment

2. Major injury at time of screen or study procedures

3. Taking ≥20 mg morphine per day

4. Current substance use or intoxication (12-panel drug test)

5. Intellectual disability (MoCA)

6. Self-inflicted injury

7. Occupational injury

8. Prisoner

9. Ongoing domestic violence

10. Pregnant or breastfeeding

11. Contraindications for taVNS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Danielle Taylor

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tolan Park Research Clinic, Wayne State University

Detroit, Michigan, United States

Countries

United States

Central Contacts

Danielle Taylor, PhD

Role: CONTACT

dtaylo@med.wayne.edu

313-774-3606

Study Coordinator

Role: CONTACT

wsu.spark.study@gmail.com

Facility Contacts

Executive Assistant Dept of Psych. & Behav. Neurosciences

Role: primary

mcaton@med.wayne.edu

(313) 577-9510

Other Identifiers

IRB-23-05-5811

Identifier Type: -

Identifier Source: org_study_id