Validation Study of a New Digital Diagnostic and Treatment Test Based on Interactive Video Games for Alzheimer's Disease

Обзор

This study aims to validate a novel, non-invasive diagnostic and digital therapeutic approach for Alzheimer's Disease (AD), centered on an interactive video game called BGaze Therapy. This platform leverages eye-tracking technology to assess and potentially enhance cognitive functions, particularly attention and memory. The diagnostic component of the study investigates the use of eye vergence responses-elicited during a visual attention task-as potential biomarkers for early AD. Specifically, the study will re-validate eye vergence by comparing response patterns among three groups: cognitively healthy older adults, individuals with Mild Cognitive Impairment (MCI), and patients with confirmed AD, based on blood biomarkers (ßA40, ßA42, pTau181, and pTau217). The diagnostic task follows an oddball paradigm, where participants must detect target images (grapes) among distractors (other fruits) across 100 one-second trials, lasting approximately three minutes. Eye vergence is recorded using remote infrared eye-tracking, while participants simply fixate on a computer screen. The therapeutic aspect evaluates the impact of BGaze Therapy, which employs "serious games" designed to train attentional control through eye movements. The game dynamically adjusts its difficulty in real time and provides continuous feedback to enhance user engagement and learning efficacy. Participants will undergo pre-testing-including blood biomarker analysis and standardized cognitive assessments (MMSE and MoCA)-followed by a two-month training phase at care centers using the BGaze Therapy system. Post-intervention testing will mirror the pre-test protocol to assess cognitive and neurological changes. A total of 60 participants (30 with MCI and 30 with AD) will be recruited for the validation phase. A subsample (15 MCI and 15 AD participants) will be selected for the treatment phase. Ultimately, this study aims to establish BGaze as a cost-effective, scalable, and non-invasive tool for the early diagnosis and treatment of Alzheimer's Disease by addressing the attentional and cognitive deficits associated with the condition.

Вмешательства

• Устройство Bgaze Therapy
  BGaze Therapy is a digital intervention by Braingaze designed to enhance attention and memory in individuals with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI). It uses an interactive video game controlled through eye-tracking, allowing users to play using only their gaze. The therapy is based on research linking eye vergence and pupil responses to cognitive processing-physiological markers that may indicate neurodegeneration. During gameplay, these responses are modulated, potent
• Диагностический тест Bgaze Attention Task
  For the validation of diagnosis of AD with vergence method the Attention Test (B-Gaze) will be used. This is an odd ball paradigm where visual target has to be detected among blue distractors. The test consist of 100 trials of 1 second and last about 3 minutes. The task uses remote eye infra-red tracking to measure eye vergence. Subjects merely have to fixate at the computer screen during the task.

Первичные конечные точки

• Beta biomarkers [Срок оценки: Immediately after the intervention]
• PTau Biomarkers [Срок оценки: Immediately after the intervention]
• Pupil Response [Срок оценки: Immediately after the intervention]
• Ocular vergence [Срок оценки: Immediately after the intervention]

Вторичные конечные точки (1)

• Montreal Cognitive Assessment (MoCA) Score [Срок оценки: Immediately after the intervention]

Критерии участия

Критерии включения

• Aged 50 years or older.
• Clinical diagnosis of early-stage AD or MCI based the criteria of National Institute on Aging-Alzheimer's Association.
• Capable of providing informed consent.

Критерии исключения

• Severe cognitive impairment (MMSE < 10).
• Neurological conditions affecting cognition (e.g., stroke).
• Severe psychiatric disorders.
• Structural brain abnormalities (e.g., tumors) with cognitive impact.
• Significant visual impairments.
• Inability to understand or communicate in Spanish.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Braingaze — Mataró

Публикации

• Romeo A, Leonovych O, Sole Puig M, Super H. Cognitive Vergence Recorded with a Webcam-Based Eye-Tracker during an Oddball Task in an Elderly Population. Sensors (Basel). 2024 Jan 30;24(3):888. doi: 10.3390/s24030888. PMID 38339605
• Jimenez EC, Sierra-Marcos A, Romeo A, Hashemi A, Leonovych O, Bustos Valenzuela P, Sole Puig M, Super H. Altered Vergence Eye Movements and Pupil Response of Patients with Alzheimer's Disease and Mild Cognitive Impairment During an Oddball Task. J Alzheimers Dis. 2021;82(1):421-433. doi: 10.3233/JAD-201301. PMID 34024820
• Hashemi A, Leonovych O, Jiménez EC, Sierra-Marcos A, Romeo A, Valenzuala PB, et al. Classification of MCI patients using vergence eye movements and pupil responses obtained during a visual oddball test. Aging Health Res. 2023 Mar 1;3(1):100121.

Идентификаторы

NCT: NCT06963879 · PID2022-139968OB-I00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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