NCT06768112

Non-Invasive Vagus Nerve Stimulation Combine Postural Training in the Elderly

Adaptive Changes in Plasticity of Cerebrum and Cerebellum Following Innovative Postural

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This three-year research proposal aims to enhance postural control in older adults using non-invasive vagus nerve stimulation (nVNS). The study will develop a new system integrating cerebellar EEG (ECeG), EEG, and ECG to assess how nVNS combined with postural training affects individuals with early-stage frontal degeneration. In the first year, the focus will be on creating and validating the ECeG system to explore neural mechanisms of postural control. The second year will test the combined effects of ear-nVNS and dynamic posture training, examining how nVNS influences adrenal and hormone pathways. The final year will evaluate if ear-nVNS can further improve postural training with virtual feedback. Overall, the project aims to advance fall prevention strategies for older adults by exploring the role of cerebellar function and innovative training methods.

Detailed description

The interaction between the cortex and cerebellum is pivotal in adapting to diverse postural challenges. Non-invasive vagus nerve stimulation (nVNS) has recently gained attention as a therapeutic approach with potential effects on frontal facilitation and improvement of neuromotor control. It provides a promising avenue to aid postural training for older individuals experiencing early-stage frontal degeneration. This three-year proposal aims to develop an integrated electrophysiological system for cerebellar EEG (ECeG), EEG, and ECG measures, with the goal of investigating the effects of innovative postural training with nVNS on older adults, particularly those at risk of falls due to frontal aging. The primary focus will be on the reorganization of cortical networks, the functional coupling between the cortex and cerebellum, and heart rate variability, with a contextual extension to the neurovisceral integrative model. In the first year, the proposal seeks to develop and validate a cerebellar electroencephalogram (ECeG) system, integrating it with the EEG and electrocardiogram (ECG) systems to explore the neural mechanisms for postural control on varying stance configurations for the elderly. During the second year, the proposal will investigate the effectiveness and neural mechanisms of combined ear-nVNS and dynamic posture training for the elderly, utilizing the Mesocircuit model to trigger adrenal and serum hormone pathways with nVNS. In the third year, the proposal will examine whether ear-nVNS can further enhance the postural training effects of virtual error amplification feedback in dynamic posture training for the elderly. The highlights of this project include the novel application of ear-nVNS to counteract falls in the elderly due to frontal degeneration and cognitive decline, as well as pioneering approaches to explore neural mechanisms underlying postural training effects with an in vivo examination of the cerebellar role. The innovative postural training with convenience is expected to be of practical value for fall prevention in the elderly.

Conditions

• Balanced
• Aging

Interventions

Type	Name	Description
DEVICE	Non-Invasive Vagus Nerve Stimulation	Using non-invasive vagus nerve stimulation at the ear to stimulate the adrenergic and serum hormone pathways, activating the frontal lobe system, sensory-motor nervous system, and cerebellum, to investigate the effects and neural mechanisms of dynamic posture training and learning.
BEHAVIORAL	balance training	Participants will be asked to stand on a soft-platform and hit on blaze-pod LED within 60 seconds.
BEHAVIORAL	Mini-Mental State Examination	The mini-mental state examination (MMSE) or Folstein test is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-10-30
• Completion: 2027-12-31
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: Taiwan