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

National Cheng-Kung University

Status: Active, not recruiting

Conditions: Aging; Balanced

Treatments: Device: Non-Invasive Vagus Nerve Stimulation; Behavioral: Mini-Mental State Examination; Behavioral: balance training

Study type: Interventional

Funder types: Other

Identifiers

NCT06768112

NSTC 113-2314-B-006 -080 -MY3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

participants in this arm will conduct balance training without non-invasive vagal nerve stimulation.

Treatment:

Behavioral: balance training

Behavioral: Mini-Mental State Examination

non-invasive vagal nerve stimulation

Experimental group

Description:

Participants will receive non-invasive vagal nerve stimulation and balance training

Treatment:

Behavioral: balance training

Behavioral: Mini-Mental State Examination

Device: Non-Invasive Vagus Nerve Stimulation