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

NCT ID: NCT06963879

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Conditions

Alzheimer Disease; MCI

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BGaze Therapy MCI

30 Patients with Mild Cognitive Impairment for validation and 15 for therapy

Group Type: EXPERIMENTAL

Bgaze Therapy

Intervention Type: DEVICE

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, potentially inducing gamma brain oscillations associated with reduced AD pathology. Patients play at care-center for 5-10 minutes daily over two months. Equipment is provided, and both in-person and remote support ensure usability. The game adapts difficulty in real time and provides feedback to keep users engaged and stimulate cognitive function.

Bgaze Attention Task

Intervention Type: DIAGNOSTIC_TEST

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.

BGaze Therapy AD

30 Patients with Early Alzheimer's Disease for validation and 15 for therapy

Group Type: EXPERIMENTAL

Bgaze Therapy

Intervention Type: DEVICE

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, potentially inducing gamma brain oscillations associated with reduced AD pathology. Patients play at care-center for 5-10 minutes daily over two months. Equipment is provided, and both in-person and remote support ensure usability. The game adapts difficulty in real time and provides feedback to keep users engaged and stimulate cognitive function.

Bgaze Attention Task

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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, potentially inducing gamma brain oscillations associated with reduced AD pathology. Patients play at care-center for 5-10 minutes daily over two months. Equipment is provided, and both in-person and remote support ensure usability. The game adapts difficulty in real time and provides feedback to keep users engaged and stimulate cognitive function.

Intervention Type: DEVICE

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Braingaze

INDUSTRY

Sponsor Role: lead

Responsible Party

Hans Supèr

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Braingaze

Mataró, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 38339605 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34024820 (View on PubMed)

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.

Reference Type: BACKGROUND

Other Identifiers

PID2022-139968OB-I00

Identifier Type: -

Identifier Source: org_study_id