Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06595511
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-17
Brief Title:
Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In addition to ongoing drug treatments for Alzheimer Disease AD protective approaches that can halt the progression of the disease are of particular importance This project aims to develop a digital application that can monitor cognitive impairment using EEG findings proven effective at the clinical level in Alzheimer and various types of dementia including sensory entrainment and digital cognitive games
To this end a collaboration between Istanbul Medipol University and Güven Future Health Technologies Inc will develop a device featuring audio-visual sensory entrainment and digital cognitive games This device will be made available to Alzheimer patients and the differences between patients who use the application for three months patients who do not use the application and healthy controls will be evaluated through neurological examinations neuropsychological tests and EEG recordings indicating cognitive functions by the neurologist project coordinator and bursars Monthly assessments including EEG recordings will also continue at home and an application will be created to evaluate changes in cognitive functions through EEG data
By the end of the project an application that includes sensory entrainment and digital cognitive games proven effective at the clinical level using EEG findings for Alzheimer dementia patients will be developed Additionally a health kit capable of temporal monitoring of cognitive function changes through EEG data will have been developed
To this end a collaboration between Istanbul Medipol University and Güven Future Health Technologies Inc will develop a device featuring audio-visual sensory entrainment and digital cognitive games This device will be made available to Alzheimer patients and the differences between patients who use the application for three months patients who do not use the application and healthy controls will be evaluated through neurological examinations neuropsychological tests and EEG recordings indicating cognitive functions by the neurologist project coordinator and bursars Monthly assessments including EEG recordings will also continue at home and an application will be created to evaluate changes in cognitive functions through EEG data
By the end of the project an application that includes sensory entrainment and digital cognitive games proven effective at the clinical level using EEG findings for Alzheimer dementia patients will be developed Additionally a health kit capable of temporal monitoring of cognitive function changes through EEG data will have been developed
Detailed Description:
This study aims to recruit early and middle-stage Alzheimer patients aged between 60 and 75 along with age and gender-matched healthy older adults Two different Alzheimer groups will be created one group will utilize a 40 Hz sensory entrainment-integrated cognitive game kit at home while the other group will not receive any treatment The treatment group will comprise 10 Alzheimer patients who will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for 1 hour a day at least five days a week for three months Comprehensive neuropsychological assessments and electroencephalography EEG recordings will be conducted in the laboratory on the first day followed by mobile EEG recordings at home at the end of the first and second months After three months of using the sensory entrainmentcognitive game kit the participants will again undergo neuropsychological assessment and EEG recording in the laboratory The second Alzheimer group n10 will not be administered any treatment and will undergo the same assessment protocol as the treatment group Furthermore in addition to these two groups a healthy older adult group n10 will also be included in the study with assessments scheduled only on the first day and at the end of the third month
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None