Vagus Nerve Stimulation for PTSD

(SPARK-VNS Trial)

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Wayne State University

Must not be taking: Morphine

Disqualifiers: Substance use, Intellectual disability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a type of non-invasive brain stimulation, called transcutaneous auricular vagus nerve stimulation, can help reduce anxiety and fear responses in people who have experienced trauma. Researchers aim to determine if this treatment can calm anxious arousal and lessen learned fear in individuals with PTSD. The trial includes two groups: one receiving active stimulation and another receiving a sham (inactive) treatment for comparison. People who have experienced trauma and have probable PTSD might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking 20 mg or more of morphine per day.

What prior data suggests that this vagus nerve stimulation is safe for PTSD?

Research has shown that transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe. One study specifically examined its safety and found it to be a safe, non-invasive treatment, meaning it doesn't involve surgery or risky entry into the body.

Another study investigated its effects on PTSD symptoms, such as anxiety, and found it did not cause serious side effects. These findings suggest that taVNS is well-tolerated by patients.

While these studies are promising, it is important to remember that this treatment is still under investigation. Participants in clinical trials help researchers learn more about its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD?

Unlike the standard treatments for PTSD, which often involve medications like SSRIs or therapy, transcutaneous auricular vagus nerve stimulation (taVNS) offers a unique, non-invasive approach. This treatment targets the vagus nerve through the skin of the ear, potentially modulating mood and stress responses without the need for pharmaceuticals. Researchers are excited about taVNS because it could provide a safe alternative with fewer side effects, and it may enhance the body's natural ability to regulate emotions and stress. Additionally, the non-invasive nature of taVNS makes it an attractive option for those who prefer to avoid medication.

What evidence suggests that vagus nerve stimulation is effective for PTSD?

Research shows that transcutaneous auricular vagus nerve stimulation (taVNS) might help with stress-related issues. Studies have found that it can reduce anxiety and symptoms of depression. In this trial, participants will receive either active taVNS or a sham version. In people with PTSD, taVNS blocked some stress-related responses in the body. This non-invasive treatment, which doesn't require surgery, is safer. It could potentially help those who have experienced psychological trauma by easing anxious feelings and reducing learned fear. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Post-Traumatic Stress Disorder (PTSD). Participants should have experienced psychological trauma and are willing to undergo non-invasive brain stimulation. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

Fluent in English

Probable PTSD (PCL-5 ≥ 32)

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

Exclusion Criteria

Self-inflicted injury

Occupational injury

Intellectual disability (MoCA)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo non-invasive vagus nerve stimulation and complete surveys and tasks to measure physiological responses

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• sham transcutaneous auricular vagus nerve stimulation
• transcutaneous auricular vagus nerve stimulation

Trial Overview

The study tests if a non-invasive method called transcutaneous auricular vagus nerve stimulation can reduce anxiety and fear in PTSD patients, compared to a sham (fake) treatment. It measures bodily responses like heart rate, sweat, startle reflexes, and uses questionnaires.

How Is the Trial Designed?

Group I: Active taVNS Experimental Treatment 1 Intervention

Active transcutaneous auricular vagus nerve stimulation

Group II: Sham taVNS Placebo Group 1 Intervention

Active transcutaneous auricular vagus nerve stimulation

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

Published Research Related to This Trial

Transcutaneous auricular vagus nerve stimulation (taVNS) is a safe and effective neuromodulation therapy for a variety of conditions, including epilepsy, depression, and anxiety, indicating its broad therapeutic potential.

Despite its effectiveness, there is currently no standardization among taVNS devices, and further research is needed to clarify the relationship between stimulation parameters and therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. Wang, L., Wang, Y., Wang, Y., et al.[2022]

In a pilot study involving 22 combat veterans, transcutaneous vagal nerve stimulation (tVNS) was found to be well tolerated and improved vagal tone, indicating a positive effect on the autonomic nervous system related to PTSD symptoms.

tVNS also moderated the autonomic response to stress, suggesting it may help regulate emotional dysregulation in veterans with PTSD, particularly those with a history of mild traumatic brain injury (mTBI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-invasive Vagal Nerve Stimulation Effects on Hyperarousal and Autonomic State in Patients with Posttraumatic Stress Disorder and History of Mild Traumatic Brain Injury: Preliminary Evidence. Lamb, DG., Porges, EC., Lewis, GF., et al.[2020]

Transcutaneous vagus nerve stimulation (tVNS) is gaining interest for its non-invasive application in research and clinical settings, but there is a need for better reporting practices to ensure safety and comparability across studies.

The review proposes a set of minimal reporting items for future tVNS studies, including technical details, participant criteria, and outcome measures, to enhance the reliability and effectiveness of this therapeutic approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). Farmer, AD., Strzelczyk, A., Finisguerra, A., et al.[2023]

Transcutaneous cervical vagal nerve stimulation (tcVNS) was shown to enhance brain activation in areas associated with trauma processing, such as the anterior cingulate and hippocampus, during exposure to traumatic stress reminders in a study of 22 participants.

Compared to sham stimulation, tcVNS resulted in significant changes in brain activity, suggesting it may help reverse neurobiological alterations linked to PTSD, potentially improving autonomic control and offering a new treatment avenue for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder. Wittbrodt, MT., Gurel, NZ., Nye, JA., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally safe, with a low incidence of mild and transient adverse effects, such as ear pain, headache, and tingling, reported in only 24.86% of the studies analyzed.

In a systematic review of 177 studies involving 6322 subjects, there was no significant difference in the risk of adverse events between taVNS and control groups, indicating that taVNS is a feasible option for clinical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. Kim, AY., Marduy, A., de Melo, PS., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive and cost-effective method for modulating the vagus nerve, making it a promising alternative to traditional surgical vagus nerve stimulation.

taVNS allows for easy and safe administration, with considerations for proper electrode placement and individual dosing based on perception thresholds, which enhances its potential for treating various central and peripheral diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. Badran, BW., Yu, AB., Adair, D., et al.[2020]

Transcutaneous Vagus Nerve Stimulation (tcVNS) significantly reduced PTSD symptoms by 31% compared to sham treatment over three months, indicating its potential efficacy as a therapeutic intervention.

tcVNS effectively blocked stress-induced increases in the inflammatory marker IL-6, suggesting that its mechanism of action may involve reducing inflammation associated with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Cervical Vagal Nerve Stimulation in Patients with Posttraumatic Stress Disorder (PTSD): A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 Response to Stress. Bremner, JD., Wittbrodt, MT., Gurel, NZ., et al.[2023]

Transcutaneous auricular vagus nerve stimulation (taVNS) is a non-invasive technique that stimulates the vagus nerve in the outer ear, potentially helping to treat pediatric neurodevelopmental and psychiatric disorders by addressing maladaptive neural plasticity.

Current literature suggests that taVNS may be a promising alternative treatment for conditions like autism spectrum disorder and ADHD, especially for children who do not respond to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic applications of transcutaneous auricular vagus nerve stimulation with potential for application in neurodevelopmental or other pediatric disorders. Zhu, S., Zhang, X., Zhou, M., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11749037/

Transauricular vagus nerve stimulation in preventing post ...

This study aims to evaluate the efficacy and safety of ta-VNS in preventing PTSD in emergency trauma surgery patients.

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nature.com

nature.com/articles/s41398-025-03535-9

Transcutaneous auricular vagus nerve stimulation ...

Transcutaneous auricular vagus nerve stimulation alleviates anxiety-like behaviors in mice with post-traumatic stress disorder by regulating ...

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sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165032723008625

Effect of transcutaneous cervical vagus nerve stimulation ...

These preliminary results suggest that tcVNS improves attention, declarative and working memory, which may improve quality of life and productivity for ...

4.

frontiersin.org

frontiersin.org/journals/digital-health/articles/10.3389/fdgth.2025.1593614/full

Effect of transcutaneous auricular vagus nerve stimulation ...

taVNS does not require invasive procedures and has been shown to effectively alleviate symptoms associated with stress-related disorders, including depression ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8580056/

A Pilot Study of Effects on PTSD Symptoms and Interleukin-6 ...

We previously showed that transcutaneous Vagus Nerve Stimulation (tcVNS) blocks inflammatory (interleukin (IL)-6) responses to stress in PTSD. The purpose of ...

6.

reporter.nih.gov

reporter.nih.gov/project-details/10459181

Project Details

The current study aims to determine whether the use of a novel, safe, non- invasive form of VNS, transcutaneous auricular VNS (taVNS), would be acceptable and ...

7.

tandfonline.com

tandfonline.com/doi/full/10.2217/bem-2018-0002

Full article: Is There a Role for Vagus Nerve Stimulation in ...

Non-invasive vagal nerve stimulation effects on hyperarousal and autonomic state in patients with post-traumatic stress disorder and history of mild traumatic ...