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Not yet recruiting NCT07087951

Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)

No phase Interventional EEG Brain Oscillations Alzheimer's Disease (AD) and Related Disorders Cognitive Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gamma auditory stimulation device (active setting), Gamma auditory stimulation device (sham setting).
Who it may be relevant to
Registry conditions: EEG Brain Oscillations, Alzheimer's Disease (AD) and Related Disorders, Cognitive Dysfunction. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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)

Overview

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.

Interventions

  • Device 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 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.

Primary outcome measures

  • Changes in neurophysiological function. [Time frame: baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)]
Secondary outcome measures (12)
  • 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 Taylor Complex Figure Test (TCFT). [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 (NPI) [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)]

Eligibility criteria

Inclusion criteria

  • Age over 60 years old.
  • MMSE≤ 24
  • CDR scores of 0.5 and 1
  • Voluntary to sign the Informed Consent Form.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung University — Taoyuan

Identifiers

NCT: NCT07087951 · 202402079B0A3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗