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

60 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment for PTSD?

Research suggests that transcutaneous vagus nerve stimulation (tVNS) may help improve symptoms of PTSD by affecting brain systems related to stress and emotional regulation. Studies have shown that tVNS can improve sleep quality, reduce stress responses, and enhance emotional regulation in individuals with PTSD, indicating its potential as a treatment option. ^{1 2 3 4 5}

Is transcutaneous auricular vagus nerve stimulation (taVNS) safe for humans?

Transcutaneous auricular vagus nerve stimulation (taVNS) is generally considered safe, with mild and temporary side effects like ear pain, headache, and tingling. Studies show no link between taVNS and serious side effects, making it a safe option for clinical use. ^{6 7 8 9 10}

How does transcutaneous auricular vagus nerve stimulation (taVNS) differ from other PTSD treatments?

Transcutaneous auricular vagus nerve stimulation (taVNS) is unique because it is a non-invasive, non-surgical treatment that stimulates the vagus nerve through the ear to help regulate the body's stress response and improve symptoms of PTSD. Unlike traditional medications or therapies, taVNS directly targets the nervous system to modulate brain activity and autonomic functions, potentially offering a safe and portable option for managing PTSD symptoms. ^{1 2 3 5 10}

What is the purpose of this trial?

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?

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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 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 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]

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]

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]

References

1. Switzerland 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. [2020]

2. Netherlands 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Preliminary evidence of transcutaneous vagus nerve stimulation effects on sleep in veterans with post-traumatic stress disorder. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficient parameters of vagus nerve stimulation to enhance extinction learning in an extinction-resistant rat model of PTSD. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Noninvasive Cervical Vagal Nerve Stimulation Alters Brain Activity During Traumatic Stress in Individuals With Posttraumatic Stress Disorder. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcutaneous auricular vagus nerve stimulation (taVNS): a systematic review and meta-analysis. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

International Consensus Based Review and Recommendations for Minimum Reporting Standards in Research on Transcutaneous Vagus Nerve Stimulation (Version 2020). [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Therapeutic applications of transcutaneous auricular vagus nerve stimulation with potential for application in neurodevelopmental or other pediatric disorders. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vagus nerve stimulators: a review of past, present, and future devices. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Laboratory Administration of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS): Technique, Targeting, and Considerations. [2020]