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

NCT04042922 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-10-01

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Li-Huei Tsai, PhD · Massachusetts Institute of Technology

  • Edward S Boyden, PhD · Massachusetts Institute of Technology

  • Diane Chan, MD, PhD · Massachusetts Institute of Technology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-19
Primary Completion
2026-04-30
Completion
2027-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04042922 on ClinicalTrials.gov