- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07730398
Optimizing Noisy Galvanic Vestibular Stimulation Frequency Range for Enhancing Vestibular Perception and Manual Control Performance
22 июля 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
18
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Texas
-
Houston, Texas, Соединенные Штаты, 77058
- Nasa Jsc B21
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Control - No noisy galvanic vestibular stimulation
Participants completed testing without noisy galvanic vestibular stimulation.
|
|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Vestibular Direction Recognition Threshold
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Roll-Tilt Vestibular Direction Recognition Threshold
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Следователи
- Главный следователь: Scott J Wood, PhD, National Aeronautics and Space Administration (NASA)
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
19 февраля 2024 г.
Первичное завершение (Действительный)
18 марта 2024 г.
Завершение исследования (Действительный)
18 марта 2024 г.
Даты регистрации исследования
Первый отправленный
15 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
22 июля 2026 г.
Первый опубликованный (Действительный)
28 июля 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
28 июля 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
22 июля 2026 г.
Последняя проверка
1 июля 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- eIRB Study 0530
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
ДА
Описание плана 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.
Сроки обмена IPD
For at least five years following publication.
Критерии совместного доступа к IPD
Data can be requested through the NASA Life Sciences Portal (https://www.nasa.gov/hrp/nlsp/).
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .