BalancedNCT06768112
Non-Invasive Vagus Nerve Stimulation Combine Postural Training in the Elderly
A study testing Non-Invasive Vagus Nerve Stimulation, balance training and Mini-Mental State Examination in people with Balanced and Aging, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- What is being tested?
- Non-Invasive Vagus Nerve Stimulation, balance training and Mini-Mental State Examination
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Non-Invasive Vagus Nerve Stimulation, balance training, Mini-Mental State Examination
- Keywords
- Gual-task, Invasive cervical vagus nerve stimulation, Aging, Cerebellar EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive Vagus Nerve StimulationDevice
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.
balance trainingBehavioural
Participants will be asked to stand on a soft-platform and hit on blaze-pod LED within 60 seconds.
Mini-Mental State ExaminationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | participants in this arm will conduct balance training without non-invasive vagal nerve stimulation. Receives: 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 Receives: Device: Non-Invasive Vagus Nerve Stimulation; Behavioral: balance training; Behavioral: Mini-Mental State Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive Performance
Analysis of cognitive tests including Stroop test and trail making test.
Measured: the first day, at the end of 5 days training
Brain activity
EEG Data Analysis
Measured: 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.
Measured: the first day, at the end of 5 days training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start1 Aug 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalancedStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768112
- Sponsor's protocol ID
- NSTC 113-2314-B-006 -080 -MY3
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Changes in Plasticity of Cerebrum and Cerebellum Following Innovative Postural
- ClinicalTrials.gov ID
- NCT06768112
- Acronym / sponsor ID
- NSTC 113-2314-B-006 -080 -MY3
- Keywords
- Gual-task, Invasive cervical vagus nerve stimulation, Aging, Cerebellar EEG
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: balance training, Behavioral: Mini-Mental State Examinationparticipants in this arm will conduct balance training without non-invasive vagal nerve stimulation. |
| non-invasive vagal nerve stimulation | Experimental | Device: Non-Invasive Vagus Nerve Stimulation, Behavioral: balance training, Behavioral: Mini-Mental State ExaminationParticipants will receive non-invasive vagal nerve stimulation and balance training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive Vagus Nerve StimulationUsing 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. | Device | non-invasive vagal nerve stimulation |
| balance trainingParticipants will be asked to stand on a soft-platform and hit on blaze-pod LED within 60 seconds. | Behavioural | Placebo, non-invasive vagal nerve stimulation |
| Mini-Mental State ExaminationThe 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. | Behavioural | Placebo, non-invasive vagal nerve stimulation |
Primary outcome
Cognitive Performance
Time frame: the first day, at the end of 5 days training
Analysis of cognitive tests including Stroop test and trail making test.
Brain activity
Time frame: the first day, at the end of 5 days training
EEG Data Analysis
Kinematic Analysis of Upper and Lower Limb Dynamics
Time frame: the first day, at the end of 5 days training
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Vagus Nerve Stimulation, balance training and Mini-Mental State Examination in people with Balanced and Aging, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Performance (time frame: the first day, at the end of 5 days training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.