Efficacy of Gamma Auditory Stimulation for Cognitive Decline in Older Adults (Study 1)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 60 years old.
MMSE≤ 24
CDR scores of 0.5 and 1
Voluntary to sign the Informed Consent Form.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Gamma auditory stimulation device (active setting)
DeviceParticipants 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)
DeviceParticipants 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: 40Hz music groupExperimental treatment 1 intervention
Group B: Non-40Hz music groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)Secondary outcomes
1
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)2
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
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)3
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)4
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.
Time frame
baseline (T1), through intervention completion, an average of 3 month (T2), three-month after intervention completion (T3)Sponsors and contacts
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Source ClinicalTrials.gov