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Optimizing Noisy Galvanic Vestibular Stimulation Frequency Range for Enhancing Vestibular Perception and Manual Control Performance

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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

18

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: Control - No noisy galvanic vestibular stimulation
Participants completed testing without noisy galvanic vestibular stimulation.
Experimental: Low-frequency noisy galvanic vestibular stimulation
Participants received low-frequency noisy galvanic vestibular stimulation during testing. Low frequency was 0-2 Hz.
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.
Experimental: High-frequency noisy galvanic vestibular stimulation
Participants received high-frequency noisy galvanic vestibular stimulation during testing. High-frequency was 10-30 Hz.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Vestibular Direction Recognition Threshold
Zeitfenster: 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 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.
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.
Perceptual Motion Tracking Accuracy
Zeitfenster: 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.
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.
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.
Manual Control Nulling Accuracy
Zeitfenster: 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.
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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Roll-Tilt Vestibular Direction Recognition Threshold
Zeitfenster: 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 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.
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.
Interaural Translation Vestibular Direction Recognition Threshold
Zeitfenster: 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.
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 Direction Recognition Bias
Zeitfenster: 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.
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.
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.
Perceptual Motion Tracking Variability
Zeitfenster: 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.
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.
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.
Manual Control Nulling Variability
Zeitfenster: 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.
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.
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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Hauptermittler: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

19. Februar 2024

Primärer Abschluss (Tatsächlich)

18. März 2024

Studienabschluss (Tatsächlich)

18. März 2024

Studienanmeldedaten

Zuerst eingereicht

15. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. Juli 2026

Zuerst gepostet (Tatsächlich)

28. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

28. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • eIRB Study 0530

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

For at least five years following publication.

IPD-Sharing-Zugriffskriterien

Data can be requested through the NASA Life Sciences Portal (https://www.nasa.gov/hrp/nlsp/).

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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