Effects of Combined 40 Hz Audio-visual Stimulation and Cognitive Games on Alzheimer's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-86
SponsorIstanbul Medipol University Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Diagnosed with AD according to DSM-IV and NINCDS-ADRDA criteria,

Impaired activities of daily living,

Having a CDR score of 1-2 and an SMMT score of 15-26,

Stable use of psychoactive medications, including acetylcholinesterase inhibitors or other medications that enhance cognitive functions,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sensory Entrainment-Integrated Cognitive Game Kit

    Device

    Active comparator group will engage with the 40 Hz sensory entrainment-integrated cognitive game kit for one hour a day, at least five days a week, for three months.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Alzheimer's Disease Treatment GroupActive comparator 1 intervention
Group B: Alzheimer's Disease Control GroupNo intervention 0 interventions
Group C: Healthy Older Adult GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

EEG recording

EEG will be recorded under these conditions: * Spontaneous EEG (8 minutes eyes open, 8 minutes eyes closed) * Visual oddball * Auditory oddball * 40 Hz flicker stimulation EEG recording (8 minutes eyes open, 8 minutes eyes closed)

Time frame
At baseline and month 3

Secondary outcomes

1

Standardized Mini Mental State Examination (SMMSE)

For the comprehensive cognitive status

Time frame
At baseline and month 3
2

Verbal memory processes test (Öktem-SBST) and Wechsler Visual Production Subtest

For the assessment of memory functions

Time frame
At baseline and month 3
3

WMS-R Digit Span Test

For the assessment of attention

Time frame
At baseline and month 3
4

Stroop Test, Clock Drawing Test, Verbal Fluency Tests (categorical and phonemic) and Trail Making Test

For the assessments of executive function

Time frame
At baseline and month 3

Other outcomes

1

Mobile EEG recording at home

EEG will be recorded under these conditions: * Spontaneous EEG (8 minutes eyes open, 8 minutes eyes closed) * 40 Hz flicker stimulation EEG recording (8 minutes eyes open, 8 minutes eyes closed) Delta, theta, alpha, beta, gamma power spectrum and phase locking indexes will be examined.

Time frame
month 1 and 2

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Medipol University Hospital

Lead sponsor

Medipol University

Sponsor institution

The Scientific and Technological Research Council of Turkey

Collaborator

Guven Health Group

Collaborator