An Early Phase 1 interventional study of transcutaneous auricular vagus nerve stimulation and sham transcutaneous auricular vagus nerve stimulation in PTSD - Post Traumatic Stress Disorder, sponsored by Wayne State University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Wayne State University · Early Phase 1, Interventional, and Basic science
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?
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.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Wayne State University is the lead sponsor of 230 studies on the registry; 35 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Active transcutaneous auricular vagus nerve stimulation
Device: transcutaneous auricular vagus nerve stimulation
Sham transcutaneous auricular vagus nerve stimulation
Device: sham 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.
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.
Fear potentiated startle (FPS)
FPS modulation, an objective behavioral indicator of defensive reactivity, is measured during acquisition and extinction, collected using electromyogram (EMG) of the right orbicularis oculi muscle with the EMG module of the Biopac MP160 for Windows.
Time frame: From enrollment to the end of the cross over visit at week 2
Skin Conductance (SC)
SC is measured using the electrodermal activity (EDA) module of the Biopac system. Two disposable pre-gelled Ag/AgCl electrodes are placed on the hypothenar surface of the non-dominant hand. SCR is defined as the increase from SC during a 1s pre-CS+ onset baseline to SC during the 3-6s post-CS+ onset.
Time frame: From enrollment to the end of the cross over visit at week 2
Heart Rate (HR)
HR is acquired via electrocardiogram (ECG) Biopac module. Three disposable pre-gelled Ag/AgCl electrodes are used: one each on the right and left sides of the torso, 1cm below the clavicle, and a third on the inside of the left wrist. The HR response is defined as the increase in HR from a 1m baseline prior to the first airblast to 1m after first airblast.
Time frame: From enrollment to the end of the cross over visit at week 2
Unconditioned Stimulus Expectancy Ratings
Identification of threat/conditioned stimulus with reinforcement (CS+) and safety/conditioned stimulus without reinforcement (CS-) is used to assess US expectancy during fear acquisition and extinction, consistent with mentors', Jovanovic and Norrholm's, research. Individuals respond on a keypad (Cedrus, Inc.) after each trial regarding CS-US contingencies. Responses consist of 3 button presses (Yes, No, I don't know) for whether participants believe a shape (CS+/CS-) will be followed by the US.
Time frame: From enrollment to the end of the cross over visit at week 2
Subjective Units of Distress (SUDS)
SUDS is recorded pre- and post- fear acquisition and extinction, and at baseline and recovery. Arousal measures will be evaluated individually and in combination to determine multivariate effects. SUDS and objective responses will be monitored, as investigations show discordance within and between objective and subjective measures of distress. SUDS are on a scale of 0 (no anxiety/distress, calm and relaxed) to 100 (extreme anxiety/distress, worst ever experienced).
Time frame: From enrollment to the end of the cross over visit at week 2
Plan to share: Yes — A. Types and amount of scientific data expected to be generated in the project: Demographic, end user feedback, clinical (self-report surveys), and physiological data will be collected from 60 individuals with PTSD. Data will be collected, processed, and then shared at the individual level. All data will be de-identified prior to uploading to the repository. However, sufficient information necessary for generating a global unique identifier (GUID) for the NIMH data archive (NDA) will be collected for each subject. B. Scientific data that will be preserved and shared, and the rationale for doing so: Scored assessments and self-report surveys will be shared to the NDA, as well as scored physiology measures. Individual, item-level scores, may result in identification of participants, and will not be shared. Any potentially identifiable PHI will be removed from data sets. C.Study protocols, data collection instruments, data processing and scoring protocols, and syntax for data analysis.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: A. All data will be deposited to the NIMH data archive (NDA) 12 months after the study begins and will be deposited biannually following the first submission. B. Within the first 6 months of an NDA Data Submission agreement will be submitted by the PI through the NDA website, which will allow for access to the NDA Collection page where data will be submitted. The NCT# will be submitted within this agreement. Data will be findable for the research community using the NDA Collection page. An NDA study will be created for each publication and each study will be assigned a digital object identifier (DOI). The DOI will be referenced in the publication so that the research community can access the data used in the publication. C. The research community will have access 1-2 years after study end date. Publication will be linked to a study containing the data used in that publication and may be found using the DOI when the pre-print is available. NDA will determine data preservation duration.
Access criteria: NDA will control data access. Researchers will submit a data access request for broad use and must be sponsored by an NIH recognized institution and have a research-related need to access the data. The NDA data access committee will make final determination on which requests to grant.
Data sharing details ↗ · nda.nih.gov
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Start is estimated for Apr 2027; primary completion for Mar 2031, 47 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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