NCT06715995

Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults

Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults: a Randomized, Placebo-controlled, Double-blind Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• EEG Brain Oscillations
• Alzheimer's Disease (AD)
• Cognitively Normal Older Adults

Interventions

Type	Name	Description
DEVICE	Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)	Participants will receive light stimulation using the Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) for 1 hour per day, 7 days a week, over 4 weeks, for a total of 28 hours.

Timeline

• Start date: 2024-12-09
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: Taiwan