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NCT Number: NCT06595511

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

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.

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Key information

Age range

60 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location status: Recruiting

Location contact

Bahar Güntekin, PhD

CONTACT

[email protected]

+90 5326031560

About this study

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 entrainment/cognitive game kit, the participants will again undergo neuropsychological assessment and EEG recording in the laboratory. The second Alzheimer group (n=10) 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 (n=10) will also be included in the study, with assessments scheduled only on the first day and at the end of the third month.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion and Exclusion Criteria for Alzheimer Patients:

Inclusion criteria

  • 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,
  • Individuals aged 60-86 with at least 5 years of education.

Exclusion criteria

  • Having frontotemporal dementia, vascular dementia, Lewy body dementia or other types of dementia,
  • Parkinsonism, clinical depression, other mental disorders, epilepsy, drug addiction, alcohol addiction, and traumatic brain injury

Inclusion and Exclusion Criteria of Healthy Older Adults:

Inclusion criteria

  • Between the ages of 60-86
  • Without any neurological abnormalities or general cognitive impairment (MMSE above 25),
  • Not diagnosed with a neurological and/or psychiatric disease,
  • Not using neurological and/or psychiatric medication

Exclusion criteria

  • Having clinical signs of cognitive impairment, such as mild cognitive impairment, Alzheimer disease, Parkinson disease, Lewy body dementia, frontotemporal dementia, etc.
  • Epilepsy, alcohol and/or drug addiction, use of medications that affect cognitive functions, and traumatic brain injury

Treatment and study plan

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.

Primary outcomes

  1. EEG recording

    Time frame: At baseline and month 3

    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)

Secondary outcomes

  1. Standardized Mini Mental State Examination (SMMSE)

    Time frame: At baseline and month 3

    For the comprehensive cognitive status

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

    Time frame: At baseline and month 3

    For the assessment of memory functions

  3. WMS-R Digit Span Test

    Time frame: At baseline and month 3

    For the assessment of attention

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

    Time frame: At baseline and month 3

    For the assessments of executive function

  5. Boston Naming Test

    Time frame: At baseline and month 3

    For the assessment of language functions

  6. Benton Line Orientation Test and Benton Face Recognition Test

    Time frame: At baseline and month 3

    For the assessment of visuospatial functions

Other outcomes

  1. Mobile EEG recording at home

    Time frame: month 1 and 2

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bahar Güntekin, PhD

CONTACT

[email protected]

+90 5326031560

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Guven Health Group
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Development of a Sensory Entrainment-Integrated Cognitive Game Kit to Improve Cognitive Functions in Alzheimer's Disease

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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