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NCT Number: NCT06715995

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

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, Guishan, 33302, Taiwan

Location status: Recruiting

Location contact

Chia-Hsiung Cheng, Ph.D.

CONTACT

[email protected]

+886-3-211800 ext. 3854

Chia-Hsiung Cheng, Ph.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes in gamma brain oscillations.

    Time frame: baseline (T1), post one-hour intervention (T2), post one-month intervention (T3)

    Gamma (31-100Hz) brain oscillations obtained through resting-state EEG will evaluate the changes of gamma light stimulation intervention.

Secondary outcomes

  1. Change score of the Cognitive Abilities Screening Instrument (CASI).

    Time frame: baseline (T1), post one-month intervention (T3)

    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.

  2. Change score of the Chinese version Verbal Learning Test (CVVLT).

    Time frame: baseline (T1), post one-month intervention (T3)

    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.

  3. Change score of the WMS-III logical memory test

    Time frame: baseline (T1), post one-month intervention (T3)

    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

  4. Change score of the Taylor Complex Figure Test (TCFT).

    Time frame: baseline (T1), post one-month intervention (T3)

    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.

  5. Performance changes of the Trail Making Test Form A/B (TMT-A/B).

    Time frame: baseline (T1), post one-month intervention (T3)

    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.

  6. Subjective cognition decline complaint survey.

    Time frame: baseline (T1), post one-month intervention (T3)

    A 14-item Subjective Memory Complaints Questionnaire measured memory impairment. The response was restricted to either "Yes" or "No".

  7. Change score of the category Verbal Fluency Test (VFT).

    Time frame: baseline (T1), post one-month intervention (T3)

    The category VFT will be applied to measure the participant's language and executive function, with a higher score indicates better performance.

  8. Safety/Adverse event outcome measure.

    Time frame: Throughout the one-month intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Hsiung Cheng, Ph.D.

CONTACT

[email protected]

+886-3-211800 ext. 3854

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • Aleddra, Inc.

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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