Nerve Stimulation + Cognitive Training for Aging

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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

We need better tools to both enhance brain health and improve cognitive performance in healthy brain aging so that it can be delayed, reduced, or even reversed. The present proposal is designed to evaluate the pairing of cognitive training with a non-invasive neurostimulation technology that has shown promise in both increasing neuroplasticity and in enhancing cognitive performance, transcutaneous vagal nerve stimulation (tVNS).

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Nerve Stimulation + Cognitive Training for Aging?

Research suggests that transcutaneous vagus nerve stimulation (tVNS), a non-invasive method, may help improve cognitive function and memory in both healthy individuals and those with conditions like epilepsy and Alzheimer's disease. It has shown potential in promoting healthy aging by affecting brain areas involved in memory and cognition. ^{1 2 3 4 5}

Is transcutaneous vagus nerve stimulation (tVNS) safe for humans?

Transcutaneous vagus nerve stimulation (tVNS) is considered a safe, non-invasive technique that has been used in research for various conditions, including epilepsy and depression, without the surgical risks associated with implanted devices. ^{1 2 6 7 8}

How is the treatment of Nerve Stimulation + Cognitive Training for Aging different from other treatments?

This treatment is unique because it combines cognitive training with transcutaneous vagal nerve stimulation (tVNS), a non-invasive method that stimulates the vagus nerve to potentially enhance cognitive function and memory. Unlike other treatments, tVNS can modulate brain activity without surgery, offering a novel approach to improving cognitive performance in aging populations. ^{1 2 5 6 7}

Research Team

John Williamson, PhD

Principal Investigator

University of Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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) 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]

References

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

The effects of transcutaneous auricular vagal nerve stimulation on cognition in healthy individuals: A meta-analysis. [2021]

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Transcutaneous Vagus Nerve Stimulation Does Not Affect Verbal Memory Performance in Healthy Volunteers. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Vagal nerve stimulation as a promising tool in the improvement of cognitive disorders. [2021]

6. 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]

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

A literature review on the neurophysiological underpinnings and cognitive effects of transcutaneous vagus nerve stimulation: challenges and future directions. [2021]

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

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