EEG Brain OscillationsNCT06715995
Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults
A study testing Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) in people with EEG Brain Oscillations and Alzheimer's Disease (AD), run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- EEG Brain Oscillations, Alzheimer's Disease (AD), Cognitively Normal Older Adults
- What is being tested?
- Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2024to 30 Sep 2025
- Phase
- Interventional
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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
Chia-Hsiung Cheng, Ph.D.
About this study
Official title: Effects of Endogenous Gamma Light Stimulation on Brain Oscillations in Cognitively-normal Older Adults: a Randomized, Placebo-controlled, Double-blind Study
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.
Read the 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.
- Being tested
- Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)
- Keywords
- Endogenous gamma, EEG rhythms, Resting-state EEG (rs-EEG), Alzheimer's disease (AD), Cognitive function, non-flickering light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| endogenous gamma light | Active comparator | This device is an LED light source table lamp with a vertical surface measuring 16 cm by 22 cm. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The active device delivers endogenous gamma light stimulation. Receives: Device: Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) |
| Sham (70Hz) gamma light | Sham comparator | The sham device is identical in appearance to the active device. It will be positioned within arm's reach, approximately 50 cm from the participant, to ensure continuous exposure to the light stimulation. The sham device delivers 70 Hz light stimulation. Receives: Device: Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gamma brain oscillations.
Gamma (31-100Hz) brain oscillations obtained through resting-state EEG will evaluate the changes of gamma light stimulation intervention.
Measured: baseline (T1), post one-hour intervention (T2), post one-month intervention (T3)
Secondary outcomes (8)
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), post one-month intervention (T3)
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), post one-month intervention (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), post one-month intervention (T3)
Change score of the Taylor Complex Figure Test (TCFT).
TCFT (immediate recall, delayed recall) will be applied to measure the participant's memory ability. The maximum score is 36 for each recall trial, with a higher score indicating better performance.
Measured: baseline (T1), post one-month intervention (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), post one-month intervention (T3)
Subjective cognition decline complaint survey.
A 14-item Subjective Memory Complaints Questionnaire measured memory impairment. The response was restricted to either "Yes" or "No".
Measured: baseline (T1), post one-month intervention (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), post one-month intervention (T3)
Safety/Adverse event outcome measure.
Adverse events, such as fatigue, headache, dizziness, dazzling, ocular 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 one-month intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start9 Dec 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EEG Brain OscillationsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aleddra, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715995
- Sponsor's protocol ID
- 202401421B0A3
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng CH, Lu H. A randomized pilot trial of non-flickering 40 Hz light stimulation: EEG activity and cognitive outcomes in cognitively normal older adults. J Alzheimers Dis. 2026 Oct 8:13872877261494219. doi: 10.1177/13872877261494219. Online ahead of print.
PubMed 42847333