- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07730398
Optimizing Noisy Galvanic Vestibular Stimulation Frequency Range for Enhancing Vestibular Perception and Manual Control Performance
22. juli 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
18
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Texas
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Houston, Texas, Forenede Stater, 77058
- Nasa Jsc B21
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Control - No noisy galvanic vestibular stimulation
Participants completed testing without noisy galvanic vestibular stimulation.
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Vestibular Direction Recognition Threshold
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Roll-Tilt Vestibular Direction Recognition Threshold
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
19. februar 2024
Primær færdiggørelse (Faktiske)
18. marts 2024
Studieafslutning (Faktiske)
18. marts 2024
Datoer for studieregistrering
Først indsendt
15. juli 2026
Først indsendt, der opfyldte QC-kriterier
22. juli 2026
Først opslået (Faktiske)
28. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- eIRB Study 0530
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
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-delingstidsramme
For at least five years following publication.
IPD-delingsadgangskriterier
Data can be requested through the NASA Life Sciences Portal (https://www.nasa.gov/hrp/nlsp/).
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
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