EEG Brain OscillationsNCT07087951
Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)
A study testing Gamma auditory stimulation device (active setting) in people with EEG Brain Oscillations and Alzheimer's Disease (AD) and Related Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- EEG Brain Oscillations, Alzheimer's Disease (AD) and Related Disorders, Cognitive Dysfunction
- What is being tested?
- Gamma auditory stimulation device (active setting)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Nov 2025to 1 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 60 years old.
- MMSE≤ 24
- CDR scores of 0.5 and 1
- Voluntary to sign the Informed Consent Form.
Who cannot join
- Diagnosis of other psychiatric or neurological disorders
- Drug or alcohol addictions.
- Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
- History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, Guishan, 33302
Chia-Hsiung Cheng, Ph.D., +886-3-211800 ext. 3854, ch.cheng@mail.cgu.edu.tw
About this study
Official title: Development and Validation of an Innovative Gamma Auditory Stimulation System for Older Adults With Cognitive Decline: A Randomized, Double-blind, Placebo-controlled Study (Study 1)
Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
Read the detailed description
Amyloid-beta (Aβ) aggregation and hyperphosphorylated tau protein tangles are widely recognized as the main pathological features of Alzheimer's disease (AD). Numerous domestic and international studies have demonstrated that 40 Hz gamma visual stimulation can effectively enhance 40 Hz gamma neural oscillations in healthy adults and older adults, improve cognitive performance and memory function in older adults and individuals with AD, and has shown good safety with no severe adverse effects.
Nevertheless, there are still several limitations to using 40 Hz visual stimulation as an intervention. Extended exposure to light sources may cause discomfort, affecting participants' willingness to continue. Prolonged light exposure may also increase the risk of seizures in photosensitive individuals. In addition, participants are required to actively fixate on the light source, which may reduce intervention adherence. Most importantly, the ecological validity of light-based stimulation remains low. Many studies require participants to gaze at light for at least five minutes or more, and daily sessions of up to an hour over several months are challenging to implement in daily life. To address these limitations, this project proposes using 40 Hz auditory stimulation as a more practical and sustainable intervention.
Moreover, animal studies have confirmed that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, evidence on the independent application of 40 Hz auditory stimulation in humans remains limited. Therefore, this project will adopt a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
- Conditions
- EEG Brain Oscillations, Alzheimer's Disease (AD) and Related Disorders, Cognitive Dysfunction
- Being tested
- Gamma auditory stimulation device (active setting), Gamma auditory stimulation device (sham setting)
- Keywords
- endogenous gamma, EEG rhythms, resting-state EEG (rs-EEG), Alzheimer's disease (AD), Cognitive function, auditory stimulation
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma auditory stimulation device (active setting)Device
Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours.
Gamma auditory stimulation device (sham setting)Device
Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours.
| Study group | Role | What they receive |
|---|---|---|
| 40Hz music group | Experimental | The 40Hz music is combined with 40Hz sound and music. Receives: Device: Gamma auditory stimulation device (active setting) |
| Non-40Hz music group | Sham comparator | The non-40Hz music is combined with non-40Hz sound and music. Receives: Device: Gamma auditory stimulation device (sham setting) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neurophysiological function.
The changes of power spectral density (PSD), response to gamma auditory stimulation and functional connectivity (FC) at each frequency band will be analyzed by EEG data from each subject.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Secondary outcomes (14)
Change score of the Chinese version Verbal Learning Test (CVVLT).
A nine-item of CVVLT (total recall, delayed recall) will be applied to measure the participant's memory ability, with a higher score indicating better performance.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the WMS-III logical memory test
WMS-III logical memory test (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 25 for each recall trial, with a higher score indicating better performance
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Benson Complex Figure Test.
Benson Complex Figure Test will be applied to measure the participant's memory ability. The maximum score is 17 for each trial, with a higher score indicating better performance.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
A neuropsychological test used to assess cognitive impairment, particularly in the context of Alzheimer's disease. The ADAS-Cog typically has a total score ranging from 0 to 70, with higher scores indicating greater cognitive impairment.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Cognitive Abilities Screening Instrument (CASI).
CASI will be applied to measure the participant's general cognitive ability. The range of score is 0 to 100, with a higher score indicating better performance.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the category Verbal Fluency Test (VFT).
The category VFT will be applied to measure the participant's language and executive function, with a higher score indicates better performance.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Performance changes of the Trail Making Test Form A/B (TMT-A/B)
TMT-A/B will be applied to measure participant's attention and executive function. The number of seconds to complete each trial and the number of errors would be recorded, with a higher value indicating greater impairment.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Performance changes of the Digit Span Test
This is a widely used neuropsychological assessment that measures attention (Digit Span Forward), and working memory (Digit Span Backward). If the participant correctly repeats the digit sequence, the number of digits in the next sequence will increase. The test will be terminated after a set number of errors.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the neuropsychiatric Inventory Questionnaire (NPI-Q)
It evaluates 12 neuropsychiatric domains. For each symptom, the NPI-Q assesses its frequency (how often it occurs), severity (how intense it is), and the resulting caregiver distress associated with the symptom. Higher scores indicate more severe symptoms and greater caregiver burden.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Geriatric Depression Scale -short form (GDS-S)
This tool consists of 15 yes-or-no questions and is commonly used to assess depression in older adults. A higher score indicates more severe depression.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Pittsburgh Sleep Quality Index (PSQI)
It used to comprehensively assess participants' sleep quality over the past month with 19 questions. Each component is scored from 0 to 3, with higher scores indicating greater sleep problems. The total PSQI score, a sum of all component scores, will range from 0 to 21, where a score above 5 indicates poor sleep quality.
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the 5-level EuroQol-5 Dimension (EQ-5D-5L)
It used to assess an individual's quality of life with five questions and each dimension has five levels of severity. Additionally, the EQ-5D-5L includes a Visual Analog Scale, where respondents rate their overall health on a scale from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Safety/Adverse events outcome measure
Adverse events, such as fatigue, headache, dizziness, dazzling, ear pain, and others, will be recorded using a 6-point Likert scale ranging from 'not at all' to 'extremely uncomfortable' (0 = not at all, 1 = minimal discomfort, 2 = mild discomfort, 3 = tolerable, 4 = severe discomfort, 5 = extreme discomfort).
Participants will report adverse events (such as fatigue, headache, dizziness, dazzling, ocular pain, and others) using a 6-point Likert scale ranging from 'not at all' to 'extremely uncomfortable' after each light stimulation session.
Measured: Throughout the three-months intervention
Device feasibility outcome measure
Participants will answer a device feasibility questionnaire, include "how is the usability of the device", "How is your satisfaction of the user interface " ...etc. We will use a 6-point Likert scale ranging from 'not at all' to 'extremely good'.
Measured: Throughout the three-months intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start14 Nov 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EEG Brain OscillationsStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087951
- Sponsor's protocol ID
- 202402079B0A3
- Status last verified
- Aug 2026
- First submitted
- 7 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of an Innovative Gamma Auditory Stimulation System for Older Adults With Cognitive Decline: A Randomized, Double-blind, Placebo-controlled Study (Study 1)
- ClinicalTrials.gov ID
- NCT07087951
- Acronym / sponsor ID
- 202402079B0A3
- Conditions
- EEG Brain Oscillations, Alzheimer's Disease (AD) and Related Disorders, Cognitive Dysfunction
- Keywords
- endogenous gamma, EEG rhythms, resting-state EEG (rs-EEG), Alzheimer's disease (AD), Cognitive function, auditory stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 28 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Animal studies have shown that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, human studies using 40 Hz auditory stimulation alone remain limited. Therefore, this study will use a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
Detailed description
Amyloid-beta (Aβ) aggregation and hyperphosphorylated tau protein tangles are widely recognized as the main pathological features of Alzheimer's disease (AD). Numerous domestic and international studies have demonstrated that 40 Hz gamma visual stimulation can effectively enhance 40 Hz gamma neural oscillations in healthy adults and older adults, improve cognitive performance and memory function in older adults and individuals with AD, and has shown good safety with no severe adverse effects.
Nevertheless, there are still several limitations to using 40 Hz visual stimulation as an intervention. Extended exposure to light sources may cause discomfort, affecting participants' willingness to continue. Prolonged light exposure may also increase the risk of seizures in photosensitive individuals. In addition, participants are required to actively fixate on the light source, which may reduce intervention adherence. Most importantly, the ecological validity of light-based stimulation remains low. Many studies require participants to gaze at light for at least five minutes or more, and daily sessions of up to an hour over several months are challenging to implement in daily life. To address these limitations, this project proposes using 40 Hz auditory stimulation as a more practical and sustainable intervention.
Moreover, animal studies have confirmed that 40 Hz auditory stimulation alone can improve spatial memory and reduce Aβ deposition. However, evidence on the independent application of 40 Hz auditory stimulation in humans remains limited. Therefore, this project will adopt a randomized, double-blind, placebo-controlled design to investigate the effects of 40 Hz auditory stimulation on cognitive function, EEG activity, sleep quality, and quality of life in older adults with mild cognitive impairment (MCI) or mild dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40Hz music group | Experimental | Device: Gamma auditory stimulation device (active setting)The 40Hz music is combined with 40Hz sound and music. |
| Non-40Hz music group | Sham comparator | Device: Gamma auditory stimulation device (sham setting)The non-40Hz music is combined with non-40Hz sound and music. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age over 60 years old.
- MMSE≤ 24
- CDR scores of 0.5 and 1
- Voluntary to sign the Informed Consent Form.
Key exclusion criteria (4 listed)
- Diagnosis of other psychiatric or neurological disorders
- Drug or alcohol addictions.
- Serious heart, liver or kidney disorders, and visual, auditory or motor impairments interfering with neuropsychological tests.
- History of clinical stroke, major depressive disorder or dysthymic disorder according to the DSM-5.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gamma auditory stimulation device (active setting)Participants will receive auditory stimulation using the gamma auditory stimulation device (active setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours. | Device | 40Hz music group |
| Gamma auditory stimulation device (sham setting)Participants will receive auditory stimulation using the gamma auditory stimulation device (sham setting) for 1 hour per day, 5 days a week, over 12 weeks, for a total of 60 hours. | Device | Non-40Hz music group |
Primary outcome
Changes in neurophysiological function.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
The changes of power spectral density (PSD), response to gamma auditory stimulation and functional connectivity (FC) at each frequency band will be analyzed by EEG data from each subject.
14 secondary outcomes
Change score of the Chinese version Verbal Learning Test (CVVLT).
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the WMS-III logical memory test
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Benson Complex Figure Test.
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Cognitive Abilities Screening Instrument (CASI).
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the category Verbal Fluency Test (VFT).
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Performance changes of the Trail Making Test Form A/B (TMT-A/B)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Performance changes of the Digit Span Test
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the neuropsychiatric Inventory Questionnaire (NPI-Q)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Geriatric Depression Scale -short form (GDS-S)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Change score of the 5-level EuroQol-5 Dimension (EQ-5D-5L)
Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)
Safety/Adverse events outcome measure
Time frame: Throughout the three-months intervention
Device feasibility outcome measure
Time frame: Throughout the three-months intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for EEG Brain Oscillations
Recruiting
Transcranial Alternating Current Stimulation (tACS) in Stuttering
Stuttering, Adult, Stuttering, Childhood
RecruitingObservational study
Relationship Between Visuospatial Attention and Balance
Balance Assessment, Visuospatial/Perceptual Abilities
Active, not recruiting
Studying the Effects of Brain Stimulation on Cognitive Control and Associated EEG in Human Subjects.
Cognitive Deficit
Not yet recruiting
Investigating the Effectiveness of Personalized Optimal Gamma Auditory Frequency Stimulation Intervention on Cognitive Function Enhancement
Gamma Oscillations, Healthy Adults
Recruiting
Sleep TMS for Depression
Major Depression, Sleep
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gamma auditory stimulation device (active setting) in people with EEG Brain Oscillations and Alzheimer's Disease (AD) and Related Disorders, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chia-Hsiung Cheng, Ph.D. (+886-3-211800 ext. 3854, ch.cheng@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neurophysiological function. (time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.