BalancedNCT05570890
Immediate Effect of Electrical Noise Stimulation on Neuromuscular Adaptation of Balance
A study testing electrical noise stimulation and Foam in people with Balanced and Electroencephalography, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
Noise stimulation had an immediate effect on improving balance control. The present study aimed to clarify the immediate neuromuscular adaptation induced by noise stimulation and find the correlation between neuromuscular adaptation and functional performance. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Balanced, Electroencephalography, Electromyography
- What is being tested?
- electrical noise stimulation and Foam
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Apr 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 20 and 40 years old
- without ankle injury history in 1 year
- without musculoskeletal or neurological diseases that would affect balance performance
- without visual impairment (except vision correction or no visual problems)
- without vestibular impairment.
Who cannot join
- subject who cannot tolerate the cutaneous electrical stimulation to induce H reflex
- single-leg stance (SLS) without support is shorter than 80 secs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effect of Electrical Noise Stimulation on Neuromuscular Adaptation During Single-Leg Stance in Healthy Young
Noise stimulation had an immediate effect on improving balance control. The present study aimed to clarify the immediate neuromuscular adaptation induced by noise stimulation and find the correlation between neuromuscular adaptation and functional performance.
Read the detailed description
The mechanism behind noise stimulation is called Stochastic Resonance which improves the detectivity of sensory input with the presence of noise, making sub-sensory threshold input detectable. Noise stimulation had been proved to improve postural control, Ia afferent sensitivity, and muscle activity of the tibialis anterior. With this evidence of the effect of noise stimulation on balance enhancement, the neuromuscular adaptation induced by noise stimulation has not been researched yet. Therefore, the present study aims to clarify the immediate effect of noise on neuromuscular regulation during postural control.
- Conditions
- Balanced, Electroencephalography, Electromyography
- Being tested
- electrical noise stimulation, Sham stimulation, Foam
- Keywords
- Center of pressure, Electroencephalography, Electromyography, H reflex, Electrical noise stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical noise stimulationDevice
The intensity of electrical noise stimulation will be set at 90% of the sensory threshold of each participant.
Sham stimulationDevice
Participants will not receive stimulation.
FoamDevice
The foam will be used to make an unstable surface.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation on stable surface | Experimental | The participant will not receive stimulation and will stand on flat ground. Receives: Device: Sham stimulation |
| Noise stimulation on stable surface | Experimental | The participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on flat ground. Receives: Device: electrical noise stimulation |
| Sham stimulation on unstable surface | Experimental | The participant will not receive stimulation and will stand on foam. Receives: Device: Sham stimulation; Device: Foam |
| Noise stimulation on unstable surface | Experimental | The participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on foam. Receives: Device: electrical noise stimulation; Device: Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean sway path of the center of pressure
The mean sway path in mm will represent balance performance
Measured: 40 seconds under each condition
Mean sway velocity of the center of pressure
The mean sway velocity in mm/sec will represent balance performance
Measured: 40 seconds under each condition
Cortical excitability
Power spectrum density of EEG will calculated for representing cortical excitability.
Measured: 40 seconds under each condition
Spinal reflex excitability
H reflex amplitude will represent the excitability of peripheral control from spinal level nerve system.
Measured: 40 seconds under each condition
Co-activation index
Co-activation index will be calculated by EMG activity of Tibialis Anterior and Soleus muscle to represent the muscle activity.
Measured: 40 seconds after each condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start29 Apr 2022
- Primary completion30 Nov 2022 (estimated)
- Study completion31 Jan 2023 (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 Yang Ming Chiao Tung UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Study director, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570890
- Sponsor's protocol ID
- YM111060E
- Status last verified
- Jul 2022
- First submitted
- 14 Aug 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The informed Consent Form used in this research does not mention IPD sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Electrical Noise Stimulation on Neuromuscular Adaptation During Single-Leg Stance in Healthy Young
- ClinicalTrials.gov ID
- NCT05570890
- Acronym / sponsor ID
- YM111060E
- Conditions
- Balanced, Electroencephalography, Electromyography
- Keywords
- Center of pressure, Electroencephalography, Electromyography, H reflex, Electrical noise stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 29 Apr 2022 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 7 Oct 2022 (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.
Noise stimulation had an immediate effect on improving balance control. The present study aimed to clarify the immediate neuromuscular adaptation induced by noise stimulation and find the correlation between neuromuscular adaptation and functional performance.
Detailed description
The mechanism behind noise stimulation is called Stochastic Resonance which improves the detectivity of sensory input with the presence of noise, making sub-sensory threshold input detectable. Noise stimulation had been proved to improve postural control, Ia afferent sensitivity, and muscle activity of the tibialis anterior. With this evidence of the effect of noise stimulation on balance enhancement, the neuromuscular adaptation induced by noise stimulation has not been researched yet. Therefore, the present study aims to clarify the immediate effect of noise on neuromuscular regulation during postural control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation on stable surface | Experimental | Device: Sham stimulationThe participant will not receive stimulation and will stand on flat ground. |
| Noise stimulation on stable surface | Experimental | Device: electrical noise stimulationThe participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on flat ground. |
| Sham stimulation on unstable surface | Experimental | Device: Sham stimulation, Device: FoamThe participant will not receive stimulation and will stand on foam. |
| Noise stimulation on unstable surface | Experimental | Device: electrical noise stimulation, Device: FoamThe participant will receive stimulation with intensity set at 90% of their sensory threshold and will stand on foam. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age between 20 and 40 years old
- without ankle injury history in 1 year
- without musculoskeletal or neurological diseases that would affect balance performance
- without visual impairment (except vision correction or no visual problems)
- without vestibular impairment.
Key exclusion criteria (2 listed)
- subject who cannot tolerate the cutaneous electrical stimulation to induce H reflex
- single-leg stance (SLS) without support is shorter than 80 secs
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 |
|---|---|---|
| electrical noise stimulationThe intensity of electrical noise stimulation will be set at 90% of the sensory threshold of each participant. | Device | Noise stimulation on stable surface, Noise stimulation on unstable surface |
| Sham stimulationParticipants will not receive stimulation. | Device | Sham stimulation on stable surface, Sham stimulation on unstable surface |
| FoamThe foam will be used to make an unstable surface. | Device | Noise stimulation on unstable surface, Sham stimulation on unstable surface |
Primary outcome
Mean sway path of the center of pressure
Time frame: 40 seconds under each condition
The mean sway path in mm will represent balance performance
Mean sway velocity of the center of pressure
Time frame: 40 seconds under each condition
The mean sway velocity in mm/sec will represent balance performance
Cortical excitability
Time frame: 40 seconds under each condition
Power spectrum density of EEG will calculated for representing cortical excitability.
Spinal reflex excitability
Time frame: 40 seconds under each condition
H reflex amplitude will represent the excitability of peripheral control from spinal level nerve system.
Co-activation index
Time frame: 40 seconds after each condition
Co-activation index will be calculated by EMG activity of Tibialis Anterior and Soleus muscle to represent the muscle activity.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: No. The informed Consent Form used in this research does not mention IPD sharing.
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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.
Li-Wei Chou, PhD study director
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical noise stimulation and Foam in people with Balanced and Electroencephalography, run by National Yang Ming Chiao Tung University 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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Oct 2022. 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. 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?
Results are not available in the source record.
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?
Mean sway path of the center of pressure (time frame: 40 seconds under each condition). The study lists 5 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 7 Oct 2022.