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

November 1, 2023 updated by: Massachusetts Institute of Technology

Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Cambridge, Massachusetts, United States, 02139
        • Massachusetts Institute of Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject is between the ages of 50 - 100.
  • Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26.
  • Subject is willing to sign informed consent document.
  • If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.

Exclusion Criteria:

  • Subjects who do not have healthcare.
  • Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
  • Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
  • Subjects with history of seizure or epilepsy within the past 24 months.
  • Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
  • Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
  • Active treatment with one or more anti-epileptic agent.
  • Subjects who have had a stroke within the past 24 months.
  • Subjects diagnosed with migraine headache.
  • Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
  • Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
  • Subjects who have profound hearing or visual impairment.
  • Subjects who have a life expectancy of less than 2 years.
  • Subjects who are pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exposure to active stimulation for 30 - 60 min
Subjects in this arm will receive 30 - 60 minutes of active stimulation
Device: GENUS device (Active Settings)
Participants in the experimental group will use the GENUS device configured to active settings for 30 - 60 minutes.
Other Names:
  • Gamma frequency stimulation
  • Light and sound stimulation
Sham Comparator: Exposure to control stimulation for 30 - 60 min
Subjects in this arm will receive 30 - 60 minutes of control stimulation
Device: GENUS device (Sham Settings)
Participants in the control group will use the GENUS device configured to sham settings for 30 - 60 minutes.
Other Names:
  • Gamma frequency stimulation
  • Light and sound stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of gamma frequency stimulation
Time Frame: Immediately after the completion of the stimulation
Feasibility of gamma frequency stimulation in subjects with mild AD will be assessed by analyzing the EEG data from each subject for a sign of change in gamma frequency waves and determining the percent of subjects who show this change.
Immediately after the completion of the stimulation
Tolerability of gamma frequency stimulation
Time Frame: Immediately after the completion of the stimulation
Tolerability of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation.
Immediately after the completion of the stimulation
Safety of gamma frequency stimulation
Time Frame: Immediately after the completion of the stimulation
Safety of gamma frequency stimulation will be assessed by using a questionnaire asking for any adverse effects of the stimulation.
Immediately after the completion of the stimulation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in working memory after gamma frequency stimulation
Time Frame: Baseline and immediately after the completion of the stimulation

Exploratory measure to check if there is any change in n-back test performance, between baseline and immediately after the completion of the stimulation.

The n-back test involves a sequence of stimuli (e.g., letters, numbers), presented one at a time, and a subject is asked to indicate when the current stimulus is the same as the stimulus presented n times earlier in the sequence. The performance metrics will include the "hit" rate (number of correct responses out of total number of target stimuli; ranging from 0 to 1), "false alarm" rate (number of incorrect responses out of total number of non-target stimuli; ranging from 0 to 1), and response time.
Baseline and immediately after the completion of the stimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts Institute of Technology

Investigators

  • Principal Investigator: Li-Huei Tsai, PhD, Massachusetts Institute of Technology
  • Principal Investigator: Edward S Boyden, PhD, Massachusetts Institute of Technology
  • Principal Investigator: Diane Chan, MD, PhD, Massachusetts Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2019

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

August 1, 2019

First Posted (Actual)

August 2, 2019

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 1, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1902706647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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