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

Trial Summary

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 data supports the effectiveness of the treatment Transcutaneous Vagus Nerve Stimulation (tVNS) for older adults?

Research shows that tVNS can improve autonomic function (the part of the nervous system that controls involuntary actions) and some aspects of quality of life, mood, and sleep in older adults. It has also been effective in managing drug-resistant epilepsy and depression, offering a non-invasive alternative to traditional vagus nerve stimulation. ^{1 2 3 4 5}

How does vagus nerve stimulation differ from other treatments for older adults?

Vagus nerve stimulation (VNS) is unique because it is a non-invasive treatment that uses electrical impulses to stimulate the vagus nerve, which can improve autonomic function, mood, and sleep in older adults. Unlike other treatments, it does not require surgery and can be administered using surface electrodes, making it safer and more tolerable, especially for older populations. ^{2 3 6 7 8}

What is the purpose of this trial?

The goal of this study is to learn about the effect of applying transcutaneous vagus nerve stimulation (tVNS) during motor training on motor learning in older adults. The main question it aims to answer is whether applying tVNS after successful motor trials (post-success tVNS) will facilitate the rate of motor learning. Participants will be randomly assigned to tVNS or sham group and receive tVNS or sham, respectively, at the outer ear during finger control training sessions. Finger control performance will be tested before and after the training sessions without outer ear stimulation.

Research Team

Minoru Shinohara, PhD

Principal Investigator

Georgia Institute of Technology

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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) 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) 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]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation for the treatment of drug-resistant epilepsy: a meta-analysis and systematic review. [2022]

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

Effects of transcutaneous vagus nerve stimulation in individuals aged 55 years or above: potential benefits of daily stimulation. [2020]

3. United States 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. [2019]

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

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

5. Netherlands pubmed.ncbi.nlm.nih.gov

Transcutaneous vagus nerve stimulation and the realm of its therapeutic hopes and physiologic enigmas. [2022]

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

Transcutaneous Auricular Vagus Nerve Stimulation in Pediatric Patients: A Systematic Review of Clinical Treatment Protocols and Stimulation Parameters. [2023]

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

Impact of transcutaneous vagus nerve stimulation on healthy cognitive and brain aging. [2023]

8. Switzerland 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. [2022]