- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07730398
Optimizing Noisy Galvanic Vestibular Stimulation Frequency Range for Enhancing Vestibular Perception and Manual Control Performance
22 lipca 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
18
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Texas
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Houston, Texas, Stany Zjednoczone, 77058
- Nasa Jsc B21
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Podstawowa nauka
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Control - No noisy galvanic vestibular stimulation
Participants completed testing without noisy galvanic vestibular stimulation.
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Vestibular Direction Recognition Threshold
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Roll-Tilt Vestibular Direction Recognition Threshold
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Śledczy
- Główny śledczy: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
19 lutego 2024
Zakończenie podstawowe (Rzeczywisty)
18 marca 2024
Ukończenie studiów (Rzeczywisty)
18 marca 2024
Daty rejestracji na studia
Pierwszy przesłany
15 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
22 lipca 2026
Pierwszy wysłany (Rzeczywisty)
28 lipca 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
28 lipca 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 lipca 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- eIRB Study 0530
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
TAK
Opis planu IPD
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.
Ramy czasowe udostępniania IPD
For at least five years following publication.
Kryteria dostępu do udostępniania IPD
Data can be requested through the NASA Life Sciences Portal (https://www.nasa.gov/hrp/nlsp/).
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .