Vagus Nerve Stimulation for Older Adults

Overseen By Minoru Shinohara, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Georgia Institute of Technology

Disqualifiers: Cardiac disease, Brain conditions, Psychiatric, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how stimulating the vagus nerve, a key nerve affecting brain and body functions, can enhance learning of new motor skills, such as finger movements, in older adults. Participants will receive either real or sham stimulation at their ear after successfully completing finger tasks. The trial aims to determine if real stimulation, known as Transcutaneous Vagus Nerve Stimulation (tVNS), improves motor learning more than the sham treatment. The study seeks right-handed adults aged 65-84 who are in good physical and mental health. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research on enhancing motor skills in older adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are being treated for a psychiatric condition, you may not be eligible to participate.

What prior data suggests that transcutaneous vagus nerve stimulation is safe for older adults?

Research has shown that transcutaneous vagus nerve stimulation (tVNS) is generally safe and well-tolerated. Most side effects are mild and temporary, with any discomfort usually not lasting long. For instance, some individuals might experience a slight tingling where the device contacts the ear.

One study found that tVNS can improve certain body functions, such as mood and sleep, without causing serious issues. This finding supports the idea that tVNS is safe to use. Although researchers are testing tVNS in older adults, previous research has confirmed its safety in various situations.

In summary, evidence suggests that tVNS is safe and might offer benefits beyond the current study's goals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcutaneous vagus nerve stimulation (tVNS) for older adults because it offers a non-invasive method to potentially enhance neurological functions. Unlike standard treatments that may involve medications or more invasive procedures, tVNS uses brief electrical currents to stimulate the vagus nerve area via the ear, which could improve brain health without the side effects typically associated with drugs. This innovative approach targets the body's natural pathways, potentially offering a safer and more accessible way to support cognitive and nervous system health in older adults.

What evidence suggests that transcutaneous vagus nerve stimulation is effective for motor learning in older adults?

Research has shown that stimulating the vagus nerve through the skin, known as tVNS, can boost brain function. This trial will test tVNS stimulation, where a brief electrical current is applied to the vagus nerve area, and compare it to a sham stimulation, where the current is applied to a non-vagus nerve area. This approach might help older adults learn new physical skills more easily. For instance, studies have found that tVNS can improve mood and sleep, which are important for maintaining brain health. Researchers believe that tVNS might support healthy aging by influencing brain chemicals and reducing inflammation. One study examined its effect on memory improvement in older adults, suggesting that tVNS could help the brain become more flexible and ready to learn new skills. ^{1 6 7 8 9}

Who Is on the Research Team?

Minoru Shinohara, PhD

Principal Investigator

Georgia Institute of Technology

Are You a Good Fit for This Trial?

This trial is for older adults interested in participating in a study to improve motor learning. Participants will be involved in finger control training sessions and must be willing to receive stimulation at the outer ear. Specific eligibility criteria are not provided, but typically these would include age restrictions and general health requirements.

Inclusion Criteria

I am physically and mentally fit.

I am between 65 and 84 years old.

Right-handed

Exclusion Criteria

Have any metal in the head such as shrapnel, surgical clips, or fragments from welding or metal work

I have had a stroke or a brain lesion.

Pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Training

Participants undergo motor training with tVNS or sham stimulation during finger control training sessions

2 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Vagus Nerve Stimulation

Trial Overview The study is testing whether transcutaneous vagus nerve stimulation (tVNS) applied after successful motor trials can speed up motor learning in aging individuals. Participants will be randomly placed into two groups: one receiving actual tVNS and the other a sham (placebo) treatment during their training sessions.

How Is the Trial Designed?

Group I: tVNS stimulation Experimental Treatment 1 Intervention

Brief electrical current will be applied to the vagus nerve area (the tragus or cymba concha, depending on the shape and size of the ear) immediately after successful trials during finger control training.

Group II: Sham stimulation Placebo Group 1 Intervention

Brief electrical current will be applied to the non-vagus nerve area (the earlobe) immediately after successful trials during finger control training.

Who Is Running the Clinical Trial?

Georgia Institute of Technology

Lead Sponsor

Trials

53

Recruited

5,600+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Published Research Related to This Trial

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 (tVNS) shows promise for treating various conditions in pediatric patients, but current studies lack specific protocols and justification for its use in this age group, as none of the 15 identified studies focused exclusively on children.

There are no dedicated tVNS devices for pediatric use, and existing studies do not adequately address neurodevelopmental considerations, highlighting the need for more research on age-appropriate stimulation parameters and protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. Sigrist, C., Torki, B., Bolz, LO., et al.[2023]

Vagus nerve stimulation (VNS) has been effectively used to treat conditions like intractable epilepsy and treatment-resistant depression, and new non-invasive methods like transcutaneous VNS (t-VNS) provide similar benefits without the risks associated with surgery.

t-VNS shows promise for improving cognitive function and neurocardiovascular stability, particularly in aging populations, by enhancing cerebral blood flow and regulating the body's parasympathetic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The Wandering Nerve Linking Heart and Mind" - The Complementary Role of Transcutaneous Vagus Nerve Stimulation in Modulating Neuro-Cardiovascular and Cognitive Performance. Dolphin, H., Dukelow, T., Finucane, C., et al.[2022]

Transcutaneous vagus nerve stimulation (tVNS) is a promising non-invasive alternative to traditional vagus nerve stimulation (VNS) for treating conditions like epilepsy and depression, which can be invasive and have side effects.

There is ongoing research into the best stimulation parameters and sites for tVNS, particularly focusing on stimulation at the outer ear, to optimize its therapeutic effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation and the realm of its therapeutic hopes and physiologic enigmas. Hilz, MJ., Bolz, A.[2022]

Transcutaneous vagus nerve stimulation (tVNS) was found to significantly increase salivary alpha amylase (SAA) levels and reduce the decline of salivary cortisol in healthy participants, indicating a modulation of hormonal indices related to noradrenergic function.

However, tVNS did not show any significant effects on psychophysiological measures such as P3 amplitude or pupil size, suggesting that while it may influence hormonal responses, it does not impact certain cognitive or physiological indices in the same way.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The neuromodulatory and hormonal effects of transcutaneous vagus nerve stimulation as evidenced by salivary alpha amylase, salivary cortisol, pupil diameter, and the P3 event-related potential. Warren, CM., Tona, KD., Ouwerkerk, L., et al.[2019]

Transcutaneous vagus nerve stimulation (tVNS) significantly reduces seizure frequency in patients with drug-resistant epilepsy, based on a meta-analysis of three studies involving 280 patients.

tVNS appears to have a low incidence of adverse effects, with headaches being the most common, making it a safer alternative for patients who cannot undergo invasive procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation for the treatment of drug-resistant epilepsy: a meta-analysis and systematic review. Wu, K., Wang, Z., Zhang, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6682519/

Effects of transcutaneous vagus nerve stimulation in ... Two weeks of daily tVNS improved measures of autonomic function, and some aspects of QoL, mood and sleep.

2. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2023.1184051/full

Impact of transcutaneous vagus nerve stimulation on ... In this review, we characterize the possible mechanisms by which non-invasive VNS may promote healthy aging (eg, neurotransmitter effects, inflammation ...

3. nature.com nature.com/articles/s41598-025-11363-6

Transcutaneous auricular vagus nerve stimulation ... This study is the first attempt to investigate taVNS effects on WM in the older adults with hearing impairment (HI) and with typical hearing (TH) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07214194

Vagus Nerve Stimulation to Enhance Memory in Aging A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10366452/

Transcutaneous Vagus Nerve Stimulation (tVNS) ... We highlight transcutaneous Vagus Nerve Stimulation (tVNS) as a neurostimulation method with unique opportunities for applications in diseases of aging.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X18302936

Safety and tolerability of Transcutaneous Vagus Nerve ... The available evidence to date suggests that tVNS is well tolerated in humans at the doses tested and is safe.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X22002078

The efficacy and safety of transcutaneous auricular vagus ... The clinical trial demonstrated that taVNS can improve cognitive performance in patients with MCI. This inexpensive, effective and innovative method can be ...

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

Safety of transcutaneous auricular vagus nerve stimulation ... Although the general impression is that taVNS is a safe technique with only mild and transient adverse effects (AEs), human data on safety and ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10394887/

Safety and feasibility of transcutaneous vagus nerve ... Older adults with MCI and dementia are at increased risk for Neuro-Cardiovascular Instability (NCVI) and Orthostatic Hypotension (OH) [28, 29].