Clinical trial NCT06715995: Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults
Official title: Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults: a Randomized, Placebo-controlled, Double-blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: EEG Brain Oscillations
Alzheimer&amp;#39;s Disease (AD)
Cognitively Normal Older Adults
Keywords: Endogenous gamma
EEG rhythms
Resting-state EEG (rs-EEG)
Alzheimer&amp;amp;#39;s disease (AD)
Cognitive function
non-flickering light
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Aleddra, Inc.
First posted: 2024-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the effects of endogenous gamma non-flickering light stimulation on resting-state EEG rhythms and cognitive function in cognitively healthy older adults. Specifically, it will assess the immediate and long-term effects of this stimulation on brainwave activity and cognitive performance. The study will explore the potential of gamma light stimulation as a non-pharmacological intervention for cognitive decline in aging populations.

Detailed description: Some Alzheimer's disease (AD) studies have investigated the effects of gamma-frequency light stimulation on healthy older adults and AD patients; they have several limitations, including small sample sizes, short intervention durations, the use of flickering light (which may cause discomfort), and lack of rigorous randomized controlled trials. The aim of this study is to address these gaps by conducting a randomized, placebo-controlled, double-blind trial.

This study will recruit 52 cognitively healthy older adults aged 55 and above (N= 52). Participants will be randomly assigned to either the experimental group (N=26), receiving endogenous gamma non-flickering light stimulation, or the control sham group (N=26), receiving 70 Hz non-flickering light stimulation. The intervention will consist of 1 hour of daily stimulation, 7 days a week, for a total of 4 weeks (28 hours). Both participants and outcomes assessors will remain blinded to group allocation.

Resting-state EEG and cognitive assessments will be conducted at three time points: prior to the intervention (T1), post one-hour intervention (T2), and post one-month intervention (T3). Resting-state brainwave activity will be the primary outcome, with data collected at all three time points (T1, T2, and T3). As secondary outcomes, cognitive assessments will be administered at T1 and T3. Adverse events will also be recorded by participants immediately following each light stimulation session.

The primary aim of this study is to assess the immediate (T2 relative to T1) and long-term (T3 relative to T1) effects of endogenous gamma light stimulation on resting-state brainwave activity. Secondary objectives include evaluating cognitive performance and assessing the safety, user acceptance, and adherence to the intervention device. The results of this study will provide valuable insights into the potential of endogenous gamma light stimulation as a non-pharmacological intervention for cognitive decline in aging populations.

Eligibility criteria: Inclusion Criteria:

* 1. Age over 55 years old.
* 2. The Cognitive Abilities Screening Instrument (CASI) score is within normal ranges adjusted for age and education.
* 3. Participants have no history of severe neurological or psychiatric disorders (such as stroke, epilepsy, depression, migraine, etc.) that could affect cognitive function.
* 4. Participants have not used drugs that may affect cognitive function (e.g., benzodiazepines, anticholinergic medications, etc.).
* 5. Participants with normal or corrected vision (e.g., glasses or contact lenses) to normal levels.
* 6. Voluntary to sign the Informed Consent Form.

Exclusion Criteria:

* 1. Participants enrolled in any cognitive enhancement study within the past two months.
* 2. Participants with a history of disease that could affect cognitive function (e.g., cancer, autoimmune diseases, etc.).
* 3. Pregnant, or planning to become pregnant.

Primary outcomes:
measure: Changes in gamma brain oscillations.
timeFrame: baseline (T1), post one-hour intervention (T2), post one-month intervention (T3)
Secondary outcomes:
measure: Change score of the Cognitive Abilities Screening Instrument (CASI).
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Change score of the Chinese version Verbal Learning Test (CVVLT).
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Change score of the WMS-III logical memory test
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Change score of the Taylor Complex Figure Test (TCFT).
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Performance changes of the Trail Making Test Form A/B (TMT-A/B).
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Subjective cognition decline complaint survey.
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Change score of the category Verbal Fluency Test (VFT).
timeFrame: baseline (T1), post one-month intervention (T3)
measure: Safety/Adverse event outcome measure.
timeFrame: Throughout the one-month intervention
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
state: Guishan
Study officials:
References: