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

NCT06595511 | Recruiting

• 1 other identifier: E-10840098-772.02-6692
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Disease; 40 Hz Stimulation; EEG Brain Oscillations

Outcome Measures

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)

  At baseline and month 3

Secondary Outcomes (6)

• Standardized Mini Mental State Examination (SMMSE)

  At baseline and month 3

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

  At baseline and month 3

• WMS-R Digit Span Test

  At baseline and month 3

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

  At baseline and month 3

• Boston Naming Test

  At baseline and month 3

Other Outcomes (1)

• Mobile EEG recording at home

  month 1 and 2

Study Arms (3)

Alzheimer's Disease Treatment Group

ACTIVE COMPARATOR

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

Device: Sensory Entrainment-Integrated Cognitive Game Kit

Alzheimer's Disease Control Group

NO INTERVENTION

Healthy Older Adult Group

NO INTERVENTION

Interventions

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.

Alzheimer's Disease Treatment Group

Eligibility Criteria

• Age: 60 Years - 86 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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
• 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
• 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

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• Guven Health Group: collaborator

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Bahar Güntekin, PhD

CONTACT

+90 5326031560; bguntekin@medipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: April 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

TU (1)