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

Adaptive Changes in Plasticity of Cerebrum and Cerebellum Following Innovative Postural

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Balanced
• Intervention / Treatment: Behavioral: balance training; Behavioral: Mini-Mental State Examination; Device: Non-Invasive Vagus Nerve Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan
    • National Chen Kong University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age: Participants aged 18-45 years (young adults) and 60-80 years (older adults).
2. Vision should be within the normal range after visual correction.
3. Lower limb strength requirement: Ability to climb stairs without holding onto anything, able to ascend 15 steps (a typical office building floor has approximately 15-20 steps).
4. No history of falls in the past six months.

Exclusion Criteria:

Here is the translation of the provided text:

1. Young adult participants: Exclude students from the Department of Physical Therapy, School of Medicine, and Institute of Behavioral Medicine at National Cheng Kung University.
2. Uncontrolled cardiovascular diseases (e.g., hypertensive patients with resting systolic blood pressure exceeding 160 mmHg).
3. Lower limb venous embolism, arterial calcification, and lymphatic issues.
4. Diabetes, sickle cell anemia, coagulation disorders, dialysis patients, and those with conditions affecting walking, lower limb musculoskeletal function, and balance issues.
5. No known psychiatric, neuromuscular, or degenerative neurological diseases.
6. Hearing impairment or those using hearing aids.
7. Dizziness caused by any lesions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; participants in this arm will conduct balance training without non-invasive vagal nerve stimulation.	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.
Experimental: non-invasive vagal nerve stimulation; Participants will receive non-invasive vagal nerve stimulation and balance training	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive Performance	Analysis of cognitive tests including Stroop test and trail making test.	the first day, at the end of 5 days training
Brain activity	EEG Data Analysis	the first day, at the end of 5 days training
Kinematic Analysis of Upper and Lower Limb Dynamics	Participants are asked to stand with both feet on a soft-pad and try to maintain a stable posture with minimal body sway. The center of pressure trajectory are taken to estimate behavioral and neurophysiological mechanisms. The dual-task involves performing simultaneous tasks of tapping LED sensor lights in real-time while standing on the soft-pad force plate.	the first day, at the end of 5 days training

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination; MMSE	A total score of 30 points; a score below 24 indicates mild cognitive impairment. Those with mild impairment will be evenly distributed into groups.	Before participating in the formal protocol, each subject must take the Mini-Mental State Examination to assess their cognitive level. This test is conducted only once per subject.

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Aging; Gual-task; Invasive cervical vagus nerve stimulation; Cerebellar EEG
• Other Study ID Numbers: NSTC 113-2314-B-006 -080 -MY3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No