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

NCT06715995 | Recruiting

• 1 other identifier: 202401421B0A3
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Endogenous gamma; EEG rhythms; Resting-state EEG (rs-EEG); Alzheimer's disease (AD); Cognitive function; non-flickering light

Outcome Measures

Primary Outcomes (1)

• Changes in gamma brain oscillations.

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

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

Secondary Outcomes (8)

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

  baseline (T1), post one-month intervention (T3)

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

  baseline (T1), post one-month intervention (T3)

• Change score of the WMS-III logical memory test

  baseline (T1), post one-month intervention (T3)

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

  baseline (T1), post one-month intervention (T3)

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

  baseline (T1), post one-month intervention (T3)

Study Arms (2)

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.

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.

Device: Gamma Wave Stimulation Table Lamp (Aleddra, Inc., USA)

Interventions

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.

Sham (70Hz) gamma light; endogenous gamma light

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Aleddra, Inc.: collaborator

Study Sites (1)

Chang Gung University

Taoyuan District, Guishan, 33302, Taiwan

RECRUITING

Central Study Contacts

Chia-Hsiung Cheng, Ph.D.

CONTACT

+886-3-211800; ch.cheng@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: December 9, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)