- ICH GCP
- USA klinikai vizsgálatok nyilvántartása
- Klinikai vizsgálat NCT07730398
Optimizing Noisy Galvanic Vestibular Stimulation Frequency Range for Enhancing Vestibular Perception and Manual Control Performance
2026. július 22. frissítette: National Aeronautics and Space Administration (NASA)
Assessments of Performance in Healthy Control Subjects
This randomized crossover interventional study evaluated the effects of different frequency ranges of noisy galvanic vestibular stimulation (nGVS) on vestibular perception, perceptual motion tracking, and manual control performance in healthy adults.
Each participant completed three experimental conditions in randomized order: no stimulation (control), low-frequency nGVS, and high-frequency nGVS.
Vestibular perceptual thresholds, perceptual tracking, and manual control performance were assessed during each condition to determine whether stimulation frequency influenced sensorimotor function.
A tanulmány áttekintése
Állapot
Befejezve
Körülmények
Részletes leírás
The purpose of this study was to investigate whether the frequency content of noisy galvanic vestibular stimulation influences vestibular perceptual sensitivity, tracking accuracy, and manual control performance.
Healthy adult participants completed a randomized crossover protocol in which they received no stimulation, low-frequency nGVS, and high-frequency nGVS during separate experimental conditions within a single study session.
Outcome measures included vestibular perceptual thresholds, tracking error rate, and measures of manual control performance.
The results were intended to improve understanding of vestibular neuromodulation and inform optimization of nGVS parameters for future aerospace and clinical applications.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
18
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Texas
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Houston, Texas, Egyesült Államok, 77058
- Nasa Jsc B21
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Igen
Leírás
Inclusion Criteria:
- Subjects were required to pass a physical exam adminisitrated by NASA JSC Clinic.
Exclusion Criteria:
- No history of neurologic, vestibular, or autonomic disease.
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Alapvető tudomány
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Crossover kiosztás
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Nincs beavatkozás: Control - No noisy galvanic vestibular stimulation
Participants completed testing without noisy galvanic vestibular stimulation.
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Kísérleti: Low-frequency noisy galvanic vestibular stimulation
Participants received low-frequency noisy galvanic vestibular stimulation during testing.
Low frequency was 0-2 Hz.
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Participants received low-frequency noisy galvanic vestibular stimulation through electrodes placed over the bilateral mastoid processes during experimental testing.
Stimulation parameters were consistent with the approved study protocol.
Frequency was 0-2Hz white noise, 300uA amplitude.
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Kísérleti: High-frequency noisy galvanic vestibular stimulation
Participants received high-frequency noisy galvanic vestibular stimulation during testing.
High-frequency was 10-30 Hz.
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Participants received high-frequency noisy galvanic vestibular stimulation through electrodes placed over the bilateral mastoid processes during experimental testing.
Stimulation parameters were consistent with the approved study protocol.
Frequency was 10-30Hz white noise, 300uA amplitude.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Vestibular Direction Recognition Threshold
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Vestibular perceptual sensitivity was assessed using roll-tilt and interaural translation direction recognition tasks performed on a six-degree-of-freedom motion platform.
Direction recognition thresholds were estimated from participant responses using an adaptive three-down, one-up staircase procedure and cumulative Gaussian psychometric curve fitting.
Lower threshold values indicate greater vestibular sensitivity and improved perception of self-motion.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Perceptual Motion Tracking Accuracy
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Perceptual motion tracking performance was evaluated during continuous pseudorandom roll motion.
Participants used a joystick to continuously indicate their perceived direction and magnitude of platform motion.
Performance was quantified using the root mean square error (RMSE) between joystick responses and the programmed motion stimulus, with lower RMSE values indicating more accurate perception and tracking of self-motion.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Manual Control Nulling Accuracy
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Manual control performance was evaluated during continuous pseudorandom roll motion while participants used a joystick to actively minimize platform motion by generating corrective control inputs.
Performance was quantified using the root mean square error (RMSE) between the platform tilt angle and the upright position over time.
Lower RMSE values indicate more effective manual control and disturbance rejection.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Roll-Tilt Vestibular Direction Recognition Threshold
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Vestibular perceptual threshold for roll-tilt motion was measured using a computerized three-down, one-up adaptive staircase procedure during a 1 Hz sinusoidal motion stimulus.
Thresholds were estimated by fitting a cumulative Gaussian psychometric function to participants' left/right direction recognition responses.
Lower threshold values indicate greater vestibular sensitivity.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Interaural Translation Vestibular Direction Recognition Threshold
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
|
Vestibular perceptual threshold for interaural translation motion was measured using a computerized three-down, one-up adaptive staircase procedure during a 1 Hz sinusoidal motion stimulus.
Thresholds were estimated by fitting a cumulative Gaussian psychometric function to participants' left/right direction recognition responses.
Lower threshold values indicate greater vestibular sensitivity.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Vestibular Direction Recognition Bias
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Response bias during the vestibular direction recognition task was estimated from the mean of the cumulative Gaussian psychometric function.
Bias represents the stimulus magnitude at which participants were equally likely to perceive motion in either direction, providing a measure of systematic perceptual offset.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Perceptual Motion Tracking Variability
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Variability of perceptual motion tracking performance during continuous pseudorandom roll motion.
Tracking variability was quantified using statistical measures including standard deviation and variance of tracking performance, providing an assessment of the consistency and precision of participant responses.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Manual Control Nulling Variability
Időkeret: Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Variability of manual control performance during the nulling task was quantified using standard deviation, variance, and mean absolute deviation of chair tilt relative to the upright position.
These measures assessed the consistency and precision of participants' ability to minimize platform motion.
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Day 1 (single study visit): Participants completed outcome assessments during each randomized intervention condition (No nGVS, Low-Frequency nGVS, and High-Frequency nGVS). Each assessment required approximately 5 minutes to complete.
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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Nyomozók
- Kutatásvezető: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
2024. február 19.
Elsődleges befejezés (Tényleges)
2024. március 18.
A tanulmány befejezése (Tényleges)
2024. március 18.
Tanulmányi regisztráció dátumai
Először benyújtva
2026. július 15.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 22.
Első közzététel (Tényleges)
2026. július 28.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
2026. július 28.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2026. július 22.
Utolsó ellenőrzés
2026. július 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- eIRB Study 0530
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IGEN
IPD terv leírása
De-identified individual participant data underlying the results reported in the publication, including vestibular threshold measurements, perceptual motion tracking data, manual control performance data, and associated analysis code, will be made available upon reasonable request to the corresponding author.
Additional study documents, including the study protocol, statistical analysis plan, and data dictionary, will also be available to support reproducibility.
Data sharing will be subject to applicable institutional policies, IRB requirements, and any NASA data-sharing requirements in effect at the time of the request.
IPD megosztási időkeret
For at least five years following publication.
IPD-megosztási hozzáférési feltételek
Data can be requested through the NASA Life Sciences Portal (https://www.nasa.gov/hrp/nlsp/).
Az IPD megosztását támogató információ típusa
- STUDY_PROTOCOL
- NEDV
- ANALYTIC_CODE
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Nem
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