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NOT YET RECRUITING
NCT06953388
PHASE1

Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD

Sponsor: Wayne State University

View on ClinicalTrials.gov

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?

Official title: SPARK-VNS: Facilitating Adaptive Posttraumatic Processing With Non-Invasive Vagus Nerve Stimulation

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-02-01

Completion Date

2032-12

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DEVICE

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.

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.

Locations (1)

Tolan Park Research Clinic, Wayne State University

Detroit, Michigan, United States