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Набор скоро начнётся NCT07209943

Augmented Reality BCI Longitudinal Study for Persons With ALS, Stroke, TBI and SCI Utilizing Cognixion + Apple Vision Pro

Без фазы С лечением ALS (Amyotrophic Lateral Sclerosis) TBI Traumatic Brain Injury SCI - Spinal Cord Injury Stroke

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cognixion + Apple Vision Pro.
Кому может быть актуально
Состояния в реестре: ALS (Amyotrophic Lateral Sclerosis), TBI Traumatic Brain Injury, SCI - Spinal Cord Injury, Stroke. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Cognixion Pass Through Study

Обзор

The goal of this study is refine the usability of a BCI capable communication platform. The study will take place in the United States area and will enroll up to 10 participants with late stage ALS, traumatic brain injury (TBI) or spinal cord injury (SCI) that have assistive communication and computer control needs. Each subject will receive an integrated Cognixion + Apple Vision Pro device that includes an augmented reality brain computer interface and associated communication software. The study duration is 3-4 months for each participant. The key questions that will be addressed in this study are: 1. Identify the ability of individuals with target indications to use the integrated Cognixion-Apple Vision Pro system to communicate effectively. 2. Identify the ability of such individuals to learn to use BCI, ET-BCI and other modalities, and to measure their progress over time. 3. Identify the effectiveness of the different forms of input supported by the combined Cognixion-Apple Vision Pro system (BCI, eye-tracking) in allowing such individuals to communicate and have agency. 4. Identify how input such as BCI can be optimized to suit the needs of individuals (e.g., specific frequencies that work best for an individual, SNR with different frequencies, number of targets, length of recording for each frequency) and improve overall usability. 5. Identify the extent to which personalization through a large language model (LLM) affects communication. 6. Identify the appropriate capabilities to enable through an agentic communication interface. Key measures include: ITR - information transfer rate SUS - system usability scale

Вмешательства

  • Устройство Cognixion + Apple Vision Pro
    An Apple Vision Pro device, integrated with Cognixion's brain sensing band and Assisted Reality software. The integrated device enables users to construct AI assisted communication and computer control commands using a combination of attention, eye gaze and head pose.

Первичные конечные точки

  • System Usabilty Score [Срок оценки: 3-4 months]
  • Information Transfer Rate (ITR) [Срок оценки: 3-4 months]
Вторичные конечные точки (1)
  • Phrases per Minute [Срок оценки: 3-4 months from training]

Критерии участия

Критерии включения

  • Must have a designated on-site support individual who can be trained on the Cognixion system
  • Fluent in understanding English
  • 18 years or older
  • Must have one of ALS, spinal cord injury or chronic brain injury and need an assistive communication device
  • Must be able to engage in volitional eye opening and sustain eye opening independently for at least 30 minutes.
  • Must have a way to communicate apart from using the Cognixion device such as vocalizations, head nod, eye blinks, eyebrow raises, etc. At a minimum, reliable, independent way of communicating "Yes" and "No"

Критерии исключения

  • Disruption in English comprehension, either due to lack of fluent proficiency or due to a developmental/acquired language disorder (e.g. aphasia)
  • Severely hearing impaired or deaf
  • Sensitivity to flashing lights
  • Claustrophobia related to the Apple Vision Pro with comfort adapter
  • History of epilepsy and/or seizures
  • Vision disorders restricting the visual field such as glaucoma, diplopia (double vision), nystagmus (involuntary eye movements)
  • History of vertigo or other vestibular disorders
  • Scalp that is prone to irritation, inflammation, injury, or infectious process

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Оценка устройства

Центры проведения

США · 1 центр
  • Cognixion HQ — Santa Barbara

Публикации

  • Wolpaw JR, Bedlack RS, Reda DJ, Ringer RJ, Banks PG, Vaughan TM, Heckman SM, McCane LM, Carmack CS, Winden S, McFarland DJ, Sellers EW, Shi H, Paine T, Higgins DS, Lo AC, Patwa HS, Hill KJ, Huang GD, Ruff RL. Independent home use of a brain-computer interface by people with amyotrophic lateral sclerosis. Neurology. 2018 Jul 17;91(3):e258-e267. doi: 10.1212/WNL.0000000000005812. Epub 2018 Jun 27. PMID 29950436
  • Kellmeyer P, Grosse-Wentrup M, Schulze-Bonhage A, Ziemann U, Ball T. Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing. J Neural Eng. 2018 Aug;15(4):041003. doi: 10.1088/1741-2552/aabfa5. Epub 2018 Apr 20. PMID 29676287
  • Lewis, J. R. (2018). The System Usability Scale: Past, Present, and Future. International Journal of Human-Computer Interaction, 34(7), 577-590

Идентификаторы

NCT: NCT07209943 · COG-AVP-002

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗