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

NCT06768112 | Active Not Recruiting

• 1 other identifier: NSTC 113-2314-B-006 -080 -MY3
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Balanced; Aging

Keywords

Gual-task; Invasive cervical vagus nerve stimulation; Aging; Cerebellar EEG

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Mini-Mental State Examination; MMSE

  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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Behavioral: balance training; Behavioral: Mini-Mental State Examination

non-invasive vagal nerve stimulation

EXPERIMENTAL

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

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

Interventions

Non-Invasive Vagus Nerve Stimulation DEVICE

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.

non-invasive vagal nerve stimulation

balance training BEHAVIORAL

Participants will be asked to stand on a soft-platform and hit on blaze-pod LED within 60 seconds.

Placebo; non-invasive vagal nerve stimulation

Mini-Mental State Examination BEHAVIORAL

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.

Placebo; non-invasive vagal nerve stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: Participants aged 18-45 years (young adults) and 60-80 years (older adults).
• Vision should be within the normal range after visual correction.
• 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).
• No history of falls in the past six months.

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (1)

National Chen Kong University Hospital

Tainan, Taiwan

Location

MeSH Terms

Interventions

Mental Status and Dementia Tests

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: January 10, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)