Validation Study of a New Digital Treatment Test

Not Applicable

• Conditions: Alzheimer Disease; MCI
• Interventions: Other: BGaze therapy Alzheimer

• Registration Number: NCT04897464
• Lead Sponsor: Braingaze

Brief Summary

Oculomotor behavior and cognitive processing of visual information are intimately connected. AD patients show ocular movement problems. Oculomotor deficits are broad consisting mainly of different saccade metrics, altered pupil responses. and smaller and irregular eye vergence movements. Here we test an interactive eye-tracking game to improve eye motion control and thereby training cognitive behavior

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-13
• Study First Submitted QC: 2021-05-18
• Last Update Submitted: 2021-05-18
• Study First Posted: 2021-05-21
• Last Update Posted: 2021-05-21
• Study Start: 2021-06-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Clinical diagnosis of MCI or AD

Exclusion Criteria

1. Severe cognitive deterioration
2. History of neurological disease with clinically relevant impact on cognition
3. Severe psychiatric disorder
4. Incidental structural brain findings with impact on cognitive impairment
5. Presence of relevant visual problems

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	BGaze therapy Alzheimer	-

Primary Outcome Measures

Name	Time	Method
MoCA	immediately after the intervention	Measure changes in MoCA
MMSE	immediately after the intervention	Measure changes in MMSE

Secondary Outcome Measures

Name	Time	Method
CANTAB	immediately after the intervention	Measure changes in CANTAB tests

Trial Locations

Locations (1)

Braingaze; 🇪🇸 Mataró, Barcelona, Spain