Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Wayne State University
Study ID
NCT06953388
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • transcutaneous auricular vagus nerve stimulation — 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 transcutaneous auricular vagus nerve stimulation — 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.

Study Details

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?

Key Dates

Start date
Feb 1, 2026
Status verified
May 2025
Primary completion
Jan 1, 2031
Completion
Dec 31, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active taVNS
    Active transcutaneous auricular vagus nerve stimulation
  • Sham Comparator: Sham taVNS
    Active transcutaneous auricular vagus nerve stimulation

Primary Outcome Measure

Fear potentiated startle (FPS) [ Time Frame: From enrollment to the end of the cross over visit at week 2 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Tolan Park Research Clinic, Wayne State UniversityDetroitMichigan48201
Executive Assistant Dept of Psych. & Behav. Neurosciences
[email protected]
(313) 577-9510

Find similar trials in Detroit, MI

By research site
Tolan Park Research Clinic, Wayne State University· Detroit, MI

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