NCT04042922

High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease

Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Massachusetts Institute of Technology · Academic / Other
• Sex: All
• Age: 50 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Alzheimer's disease (AD) is characterized by significant memory loss and toxic protein deposits (amyloid and tau) in the brain. The investigators' lab found a non-invasive way to remove these toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators aim to translate this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients. 40 participants with mild Alzheimer's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light and sound stimulation for safety, feasibility, and to optimize the stimulation device for use in the mild AD population.

Detailed description

It is known that Alzheimer's disease (AD) patients have significant disruptions in brain waves, especially the gamma frequency (\~30 - 100 Hz) waves. Recently, the investigators' lab found that gamma entrainment using light and sound stimulation, which the investigators call GENUS, improves memory and decreases toxic accumulation of amyloid and tau in AD mouse models. This study aims to translate these findings in the mouse models to be used in mild Alzheimer's patients. The investigators will recruit 40 patients diagnosed with mild AD who will be randomly assigned to two study arms. Cognitive and mental health evaluations as well as memory tests will be performed on all subjects. All subjects will also be exposed to the GENUS device, which can deliver light and sound waves at different frequencies. The GENUS device is composed of a panel with light-emitting diode (LED) illumination and speakers for auditory stimulation. Each of the 2 groups will have different combinations of light and sound settings. The investigators will use electroencephalography (EEG) to check for how the participant's brain waves respond to the stimulation, and use questionnaires to evaluate for safety and tolerability.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DEVICE	GENUS device (Active Settings)	Participants in the experimental group will use the GENUS device configured to active settings for 30 - 60 minutes.
DEVICE	GENUS device (Sham Settings)	Participants in the control group will use the GENUS device configured to sham settings for 30 - 60 minutes.

Timeline

• Start date: 2019-04-19
• Primary completion: 2026-04-30
• Completion: 2027-04-30
• First posted: 2019-08-02
• Last updated: 2024-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study