PTSD - Post Traumatic Stress DisorderEarly Phase 1SPARK-VNSNCT06953388
Understanding Non-invasive Vagus Nerve Stimulation Effects in PTSD
A Early Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with PTSD - Post Traumatic Stress Disorder, run by Wayne State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 1 Mar 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18-80
- Fluent in English
- Experience with a DSM-5 Criterion A trauma (LEC-5)
- Probable PTSD (PCL-5 ≥ 32)
Who cannot join
- Visual or Auditory impairment
- Major injury at time of screen or study procedures
- Taking ≥20 mg morphine per day
- Current substance use or intoxication (12-panel drug test)
- Intellectual disability (MoCA)
- Self-inflicted injury
Show all 11Show fewer
- Occupational injury
- Prisoner
- Ongoing domestic violence
- Pregnant or breastfeeding
- Contraindications for taVNS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Study Coordinator contact
United States1 site
Tolan Park Research Clinic, Wayne State University
Detroit, Michigan, 48201
Executive Assistant Dept of Psych. & Behav. Neurosciences, (313) 577-9510, mcaton@med.wayne.edu
About this study
Official title: SPARK-VNS: Facilitating Adaptive Posttraumatic Processing With Non-Invasive Vagus Nerve Stimulation
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?
Read the 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
- Being tested
- transcutaneous auricular vagus nerve stimulation, sham transcutaneous auricular vagus nerve stimulation
- Keywords
- PTSD, brain stimulation, fear learning, autonomics, fear potentiated startle
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
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 stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| Active taVNS | Experimental | Active transcutaneous auricular vagus nerve stimulation Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Sham taVNS | Sham comparator | Sham transcutaneous auricular vagus nerve stimulation Receives: Device: sham transcutaneous auricular vagus nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the cross over visit at week 2
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: From enrollment to the end of the cross over visit at week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start1 Apr 2027 (estimated)
- Primary completion1 Mar 2031 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Taylor, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06953388
- Sponsor's protocol ID
- IRB-23-05-5811
- Acronym
- SPARK-VNS
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPARK-VNS: Facilitating Adaptive Posttraumatic Processing With Non-Invasive Vagus Nerve Stimulation
- ClinicalTrials.gov ID
- NCT06953388
- Acronym / sponsor ID
- SPARK-VNS / IRB-23-05-5811
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, brain stimulation, fear learning, autonomics, fear potentiated startle
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 1 Mar 2031 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active taVNS | Experimental | Device: transcutaneous auricular vagus nerve stimulationActive transcutaneous auricular vagus nerve stimulation |
| Sham taVNS | Sham comparator | Device: sham transcutaneous auricular vagus nerve stimulationSham transcutaneous auricular vagus nerve stimulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 18-80
- Fluent in English
- Experience with a DSM-5 Criterion A trauma (LEC-5)
- Probable PTSD (PCL-5 ≥ 32)
Key exclusion criteria (11 listed)
- Visual or Auditory impairment
- Major injury at time of screen or study procedures
- Taking ≥20 mg morphine per day
- Current substance use or intoxication (12-panel drug test)
- Intellectual disability (MoCA)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationFDA-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 | Active taVNS |
| sham transcutaneous auricular vagus nerve stimulationFDA-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. | Device | Sham taVNS |
Primary outcome
Fear potentiated startle (FPS)
Time frame: From enrollment to the end of the cross over visit at week 2
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.
4 secondary outcomes
Skin Conductance (SC)
Time frame: From enrollment to the end of the cross over visit at week 2
Heart Rate (HR)
Time frame: From enrollment to the end of the cross over visit at week 2
Unconditioned Stimulus Expectancy Ratings
Time frame: From enrollment to the end of the cross over visit at week 2
Subjective Units of Distress (SUDS)
Time frame: From enrollment to the end of the cross over visit at week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Study Coordinator contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with PTSD - Post Traumatic Stress Disorder, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Taylor, PhD (313-774-3606, dtaylo@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear potentiated startle (FPS) (time frame: From enrollment to the end of the cross over visit at week 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.