Vagal Nerve Stimulation for Traumatic Brain Injury

Overseen By Shira Cohen-Zimerman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Depression, Substance abuse, Bioelectrical implants, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2-7 days

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the feasibility and preliminary efficacy of using transcutaneous auricular vagus nerve stimulation (tVNS) to enhance cognitive recovery in patients with mild-moderate traumatic brain injury (TBI).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Transcutaneous auricular vagus active nerve stimulation for Traumatic Brain Injury?

Research suggests that vagus nerve stimulation (VNS), including noninvasive methods like transcutaneous auricular vagus nerve stimulation (taVNS), can help improve brain function and recovery after traumatic brain injury (TBI). Studies have shown that VNS can enhance recovery of consciousness and cognitive function, and when paired with physical rehabilitation, it can improve motor function recovery in animal models. ^{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. A review of studies found no serious adverse events linked to taVNS, making it a safe option for clinical use. ^{1 2 6 7 8}

How is transcutaneous auricular vagus nerve stimulation different from other treatments for traumatic brain injury?

Transcutaneous auricular vagus nerve stimulation (taVNS) is unique because it is a noninvasive treatment that stimulates the vagus nerve through the skin of the ear, potentially improving consciousness and brain function after a traumatic brain injury. Unlike traditional therapies, it does not require surgery and has been shown to enhance brain connectivity and reduce inflammation, which may help in recovery. ^{1 2 3 8 9}

Research Team

Shira Cohen-Zimerman, PhD

Principal Investigator

Shirley Ryan AbilityLab

Eligibility Criteria

This trial is for adults aged 18-65 who are in rehab due to a recent mild-moderate traumatic brain injury. Participants must be able to use a keyboard, understand and communicate in English, provide consent, and have good orientation awareness as measured by the O-Log.

Inclusion Criteria

I can use a keyboard, understand and speak English, consent on my own, and am aware of my surroundings.

I am 18-65 years old and currently in rehab for a recent brain injury.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either active tVNS or sham stimulation while performing cognitive tasks

2-7 days

2 sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Transcutaneous auricular vagus active nerve stimulation
• Transcutaneous auricular vagus sham nerve stimulation

Trial Overview The study tests if noninvasive ear clip devices delivering vagus nerve stimulation can help with cognitive recovery after brain injury. Some participants will receive real stimulation (active), while others get fake stimulation (sham) to compare results.

Participant Groups

Group I: Transcutaneous auricular vagus nerve stimulation Active Control 1 Intervention

Active vagus nerve stimulation.

Group II: Sham Transcutaneous auricular vagus nerve stimulation Placebo Group 1 Intervention

Sham vagus nerve stimulation.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Findings from Research

Transcutaneous auricular vagus nerve stimulation (taVNS) shows potential as a treatment for disorders of consciousness, particularly in patients with a minimally conscious state (MCS), as it significantly alters brain activity measured by EEG.

In patients with MCS, taVNS led to notable changes in both delta and beta brain wave energy across multiple regions, suggesting it may enhance brain connectivity and promote awakening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vague nerve stimulation improved brain connection activity on patients of disorders of consciousness: a pilot study. Yifei, W., Yi, Y., Yu, W., et al.[2023]

Transcutaneous vagus nerve stimulation (tVNS) was found to be feasible and safe for patients with persistent impairment of consciousness after severe traumatic brain injury (TBI), with minimal side effects reported during an eight-week treatment period.

Out of five patients treated, three showed significant improvements in consciousness as measured by the Coma Recovery Scale-Revised (CRS-R), suggesting that tVNS may have potential benefits for recovery following severe TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Vagus Nerve Stimulation in Patients With Severe Traumatic Brain Injury: A Feasibility Trial. Hakon, J., Moghiseh, M., Poulsen, I., et al.[2022]

In a study involving 17 healthy adults, transcutaneous auricular vagus nerve stimulation (taVNS) at the left tragus significantly increased brain activity in areas associated with the vagal pathway, indicating its potential efficacy in neuromodulation.

Compared to control stimulation at the earlobe, tragus stimulation resulted in greater activation in key brain regions, suggesting that taVNS could be a promising therapeutic approach for influencing brain function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. Badran, BW., Dowdle, LT., Mithoefer, OJ., et al.[2020]

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]

This study will evaluate the effectiveness and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in 90 patients with Disorders of Consciousness (DoC) due to traumatic brain injury, using various assessment methods including the Coma Recovery Scale-Revised (CRS-R) and brain imaging techniques over a 40-day intervention period.

The research aims to clarify the mechanism of taVNS in promoting consciousness recovery and will also monitor adverse effects, making it a comprehensive approach to understanding this non-invasive treatment's potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial of transcutaneous auricular vagus nerve stimulation on patients with disorders of consciousness: A study protocol. Cheng, L., Sun, L., Xu, L., et al.[2023]

References

1. China pubmed.ncbi.nlm.nih.gov

Transcutaneous auricular vague nerve stimulation improved brain connection activity on patients of disorders of consciousness: a pilot study. [2023]

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

Transcutaneous Vagus Nerve Stimulation in Patients With Severe Traumatic Brain Injury: A Feasibility Trial. [2022]

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

Vagus nerve stimulation to augment recovery from severe traumatic brain injury impeding consciousness: a prospective pilot clinical trial. [2022]

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

Neurophysiologic effects of transcutaneous auricular vagus nerve stimulation (taVNS) via electrical stimulation of the tragus: A concurrent taVNS/fMRI study and review. [2020]

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

Vagus Nerve Stimulation Delivered with Motor Training Enhances Recovery of Function after Traumatic Brain Injury. [2022]

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

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

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

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

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

Randomized trial of transcutaneous auricular vagus nerve stimulation on patients with disorders of consciousness: A study protocol. [2023]

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

Vagal nerve stimulation decreases blood-brain barrier disruption after traumatic brain injury. [2022]