Vagus Nerve Stimulation for Spinal Cord Injury

Overseen By Patrick D Ganzer, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Pregnant, Prisoner, Bariatric surgery, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

16 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety of using a device to stimulate the vagus nerve around the ear for people with spinal cord injuries. The treatment, known as auricular nerve stimulation (aVNS), sends a small electrical signal to the ear for 30 minutes. Participants will undergo one session with the treatment and one without, to compare effects. Individuals who have had a spinal cord injury for at least a year, affecting movement, might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research and potentially benefit from innovative treatment.

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 prior data suggests that auricular vagal nerve stimulation (aVNS) is safe for spinal cord injury?

Research has shown that stimulating the vagus nerve in the ear (aVNS) is generally safe. Studies have found that this treatment usually causes only mild and temporary side effects, such as slight discomfort or a tingling sensation around the ear where the device is used. Most people tolerate this well, and serious side effects are rare. Although more research is underway, current evidence suggests that aVNS is a well-tolerated option for people with spinal cord injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auricular vagus nerve stimulation (aVNS) for spinal cord injury because it offers a novel approach compared to standard treatments like physical therapy and medications. Unlike these conventional methods, aVNS uses a device that delivers a low-voltage electrical signal to the ear, potentially enhancing nerve regeneration and function. This non-invasive technique is particularly appealing as it may provide therapeutic benefits with minimal side effects. Additionally, the treatment is quick, with each session lasting just 30 minutes, making it a convenient option for patients.

What evidence suggests that auricular nerve stimulation (aVNS) is effective for spinal cord injury?

Research has shown that stimulating the vagus nerve in the ear (aVNS) may assist people with spinal cord injuries. Studies have found that this method can aid in the recovery of movement and sensation. It might also enhance emotional well-being, often impacted by these injuries. In this trial, participants will experience both conditions: receiving aVNS and not receiving aVNS, to assess its effects. The treatment involves sending small electrical signals to the ear and is generally safe and well-tolerated. While researchers continue to study its effects on spinal cord injuries, similar techniques have proven effective for other conditions. Overall, early evidence suggests aVNS could be a beneficial option for those with spinal cord injuries. ^{1 2 5 6 7}

Who Is on the Research Team?

Patrick D Ganzer, PhD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals with chronic spinal cord injuries. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

I am either male or female.

I have had a spinal cord injury at the C5-T10 level for over a year.

Exclusion Criteria

Pregnant or breastfeeding

I have had weight loss surgery in the past.

Failure to satisfy inclusion criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive Auricular Vagal Nerve Stimulation (aVNS) for 30 minutes in one visit, followed by a visit without aVNS

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• auricular nerve stimulation (aVNS)

Trial Overview The safety of Auricular Vagal Nerve Stimulation (aVNS), a type of nerve stimulation therapy, is being tested on people with spinal cord injuries. Some will receive real aVNS while others get sham (fake) treatment for comparison.

How Is the Trial Designed?

Group I: no aVNS followed by aVNS in subjects with SCI Experimental Treatment 2 Interventions

Subjects will complete all study assessments without the aVNS. In the following visit, Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. Participation will be up to 2 weeks.

Group II: aVNS followed by no aVNS in subjects with SCI Experimental Treatment 2 Interventions

Auricular vagal nerve stimulation (aVNS) will be provided by a device that is placed around the ear. A low-voltage electrical signal will be given for 30 minutes. In the following visit, subjects will complete all study assessments without the aVNS. Participation will be up to 2 weeks.

auricular nerve stimulation (aVNS) is already approved in European Union, United States, China for the following indications:

Approved in European Union as taVNS for:

• Epilepsy
• Depression
• Chronic pain

Approved in United States as VNS Therapy for:

• Epilepsy
• Treatment-resistant depression

Approved in China as taVNS for:

• Stroke rehabilitation
• Spinal cord injury rehabilitation

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

In a study involving 26 subjects, simultaneous stimulation of the cymba and concha (CC) areas of the ear using extra-large electrodes was found to be the most effective for eliciting vagus somatosensory evoked potentials (VSEP), indicating strong neuromodulation effects.

The research demonstrated that the earlobe is not an effective target for taVNS, and using larger electrodes not only increased the amplitude of the response but also made the stimulation more comfortable for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of different vagus nerve stimulation anatomical targets in the ear by vagus evoked potential responses. de Gurtubay, IG., Bermejo, P., Lopez, M., et al.[2021]

Transcutaneous auricular vagus nerve stimulation (TaVNS) effectively normalized gastric dysrhythmias in healthy individuals during a water-load test, indicating its potential as a treatment for gastric symptoms.

The study found that TaVNS at 40 Hz improved heart rate variability and reduced bloating, suggesting it positively influences both parasympathetic and sympathetic nervous system pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation Normalizes Induced Gastric Myoelectrical Dysrhythmias in Controls Assessed by Body-Surface Gastric Mapping. Du, P., Maharjan, A., Calder, S., 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]

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 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]

A systematic review of 261 studies revealed significant confusion in the nomenclature for transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN), with 67 full and 27 abbreviated terms identified, highlighting the need for standardization.

The most commonly used terms were 'transcutaneous vagus nerve stimulation' and 'tVNS', but there was no consistent one-to-one relationship between full and abbreviated names, indicating a lack of uniformity in terminology across different research teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward Diverse or Standardized: A Systematic Review Identifying Transcutaneous Stimulation of Auricular Branch of the Vagus Nerve in Nomenclature. Wang, Y., Li, L., Li, S., et al.[2023]

Transcutaneous vagus nerve stimulation (tVNS) significantly reduced postural tachycardia in patients with POTS, showing a mean heart rate increase of 17.6 beats/min in the active group compared to 31.7 beats/min in the sham group after 2 months.

tVNS also led to lower levels of antiadrenergic autoantibodies and inflammatory cytokines, along with improved heart rate variability, indicating its potential as a safe and effective noninvasive treatment for POTS without any reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. Stavrakis, S., Chakraborty, P., Farhat, K., et al.[2023]

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]

Transcutaneous auricular vagus nerve stimulation (taVNS) significantly improves depression symptoms, as evidenced by reduced scores on the Hamilton Depression Scale in a review of 12 studies involving 838 participants.

taVNS shows comparable response rates to traditional antidepressants and has fewer side effects, suggesting it could be a safe alternative or complementary treatment for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and safety of transcutaneous auricular vagus nerve stimulation in the treatment of depressive disorder: A systematic review and meta-analysis of randomized controlled trials. Tan, C., Qiao, M., Ma, Y., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06588608

Auricular Vagus Nerve Stimulation (aVNS) in Chronic ... The purpose of this research is to test if Auricular Vagal Nerve Stimulation (aVNS) is safe in persons with spinal cord injury (SCI). Official Title. A Pilot ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618368/

Transcutaneous auricular vagus nerve stimulation in the ... This review provides an in-depth exploration of the mechanisms and applications of transcutaneous auricular vagus nerve stimulation (taVNS) in treating ...

3. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875023002504

Application of Vagus Nerve Stimulation in Spinal Cord ... VNS has shown promising results in alleviating these conditions in non-SCI patients, which makes it a possible therapeutic option in SCI patients.

5. journals.lww.com journals.lww.com/nrronline/fulltext/2022/08000/efficacy_and_safety_of_transcutaneous_auricular.37.aspx

Efficacy and safety of transcutaneous auricular vagus ... ta-VNS combined with conventional rehabilitation training greatly improved the recovery of motor and sensory functions and emotional responses.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8192665/

Transcutaneous Auricular Vagus Nerve Stimulation The purpose of taVNS is to treat a disease non-invasively by applying electrical current to the cutaneous receptive field formed by the auricular branch of the ...

7. ctv.veeva.com ctv.veeva.com/study/trial-of-device-that-is-not-approved-or-cleared-by-the-us-fda-998

Safety and Feasibility of Paired Transcutaneous Auricular ... The purpose of this study is to evaluate the safety and feasibility of transcutaneous auricular Vagus Nerve Stimulation (taVNS) paired with ...