Nerve Stimulation + Cognitive Training for Aging

Not currently recruiting at 1 trial location

Overseen By John Williamson, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Neurological disorders, Dementia, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore new methods to enhance brain health and slow the effects of aging on the brain. It combines cognitive training exercises with transcutaneous vagal nerve stimulation (tVNS), a non-invasive technique that may enhance brain flexibility and improve thinking skills. Participants will be divided into two groups: one will receive actual nerve stimulation, and the other will receive a sham (inactive) treatment for comparison. The trial seeks healthy individuals without neurological disorders who are ready to commit to the study requirements. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in brain health.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that transcutaneous vagal nerve stimulation (tVNS) is generally safe. This non-invasive method stimulates the vagus nerve through the skin. Most individuals who have tried tVNS experience only mild and temporary side effects, such as slight discomfort where the device touches the skin or a brief tingling sensation.

Other studies have found that tVNS is well-tolerated, making it a promising option for improving brain health without significant risk. Although it is a newer treatment, its safety record is reassuring, with few adverse effects reported in studies.

Overall, evidence suggests that tVNS can be safely used, especially when combined with cognitive training, to potentially enhance brain function as people age. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about combining cognitive training with transcutaneous vagal nerve stimulation (tVNS) because it offers a novel approach to enhancing brain health in aging individuals. Unlike traditional treatments like medications or lifestyle changes that aim to slow cognitive decline, this method directly stimulates the vagus nerve through the skin, potentially boosting brain function more effectively. The non-invasive nature of tVNS, paired with mental exercises, might provide a safer, more accessible way to improve cognitive performance without the side effects associated with drugs. This innovative combination could pave the way for more holistic and immediate interventions in cognitive aging.

What evidence suggests that this trial's treatments could be effective for healthy brain aging?

Research has shown that stimulating the vagus nerve through the skin, known as tVNS, can boost brain function. Studies have found that both young and older adults experience mental benefits, even after just one session. In this trial, participants in the tVNS group will undergo cognitive training with tVNS, a promising, non-invasive method that may help with memory problems and slow mental decline. It also improves emotional well-being, benefiting overall brain health. Combining tVNS with brain exercises might enhance these benefits, helping the brain stay healthy with age. ^{3 4 6 7 8}

Who Is on the Research Team?

John Williamson, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for healthy older adults who can commit to the study's requirements. It's not suitable for those with MRI contraindications like pregnancy or metal implants, hearing or vision deficits that affect assessments, physical impairments, traumatic brain injury, dementia signs, major psychiatric illnesses, or unstable chronic conditions.

Inclusion Criteria

Healthy individuals willing to commit to study requirements

Exclusion Criteria

MRI contraindications (e.g., pregnancy, claustrophobia, metal implants that are contraindicated for MRI).

Hearing or vision deficits that will not allow for completion of assessments

Physical impairment precluding motor response or lying still or walking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training paired with either tVNS or sham stimulation

2 weeks

Follow-up

Participants are monitored for changes in working memory and processing speed after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training
• Transcutaneous Vagal Nerve Stimulation (tVNS)

Trial Overview

The trial tests if combining cognitive training with transcutaneous vagal nerve stimulation (tVNS), a non-invasive neurostimulation method that may boost neuroplasticity and cognitive performance, can improve brain health and delay aging-related cognitive decline.

How Is the Trial Designed?

Group I: tVNS group Active Control 2 Interventions

Participants will undergo cognitive training with tVNS

Group II: Sham group Placebo Group 1 Intervention

Participants will undergo cognitive training with earlobe sham

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

McKnight Brain Research Foundation

Collaborator

Trials

3

Recruited

80+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Published Research Related to This Trial

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 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) 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]

Citations

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2828072

Transcutaneous Auricular Vagus Nerve Stimulation for ...

This randomized clinical trial investigates the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) for chronic insomnia.

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Effects of transcutaneous vagus nerve stimulation in ...

Ageing is associated with attenuated autonomic function. Transcutaneous vagal nerve stimulation (tVNS) improved autonomic function in healthy young participants ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10416636/

Impact of transcutaneous vagus nerve stimulation on healthy ...

Improvements in cognitive performance have been demonstrated in younger and older healthy adults, even after a single session of tVNS. At least ...

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Transcutaneous auricular vagus nerve stimulation ...

These studies highlight taVNS as a promising noninvasive approach for improving memory issues and potentially mitigating cognitive decline ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666956025000364

Exploring the impact of transcutaneous vagus nerve ...

In addition to its cognitive benefits, tVNS has been found to exert positive effects on emotional functioning in clinical populations, such as depression (Liu ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37532979/

Safety and feasibility of transcutaneous vagus nerve ...

Novel treatments which delay progression of MCI to dementia are urgently needed. Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive ...

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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 ...

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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 (e.g., neurotransmitter effects, inflammation ...