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Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

This study is testing a device called GENUS that uses light and sound to stimulate the brain at 40Hz. Researchers believe this stimulation might help reduce harmful proteins (amyloid and tau) and improve memory in people with Alzheimer's disease. You could be eligible if you are between 65 and 100 years old and have mild Alzheimer's disease. The study aims to see if this stimulation is safe and if it changes brain activity (gamma frequency waves) over time. The study is currently unclear on its recruitment status and plans to enroll 60 participants.

Study design
This study is an interventional study with 60 participants, where some will receive active treatment and others a sham (inactive) treatment. The phase of the study is not specified.
What's involved
You would use the GENUS device daily for 60 minutes over 6 months and attend three visits to the institution: at the beginning, at three months, and at six months.
Compensation
Not stated in the trial record.
Follow-up
Your brain activity and side effects will be assessed immediately after stimulation at the beginning, at three months, and at six months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05655195

Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

Recruiting
NAAges 65+InterventionalTreatment
Massachusetts Institute of Technology
~60 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:GENUS device (Active Settings)GENUS device (sham settings)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of gamma frequency stimulation as assessed by a change of gamma frequency waves during EEG
Measured over Immediately after completing the stimulation at baseline, month 3, and month 6 visits
+8 more outcomes measured

Conditions

Alzheimer Disease
Alzheimer Disease, Early Onset
Alzheimer Disease, Late Onset
Alzheimer's Disease (Incl Subtypes)
Alzheimer's
Alzheimer's Disease

Explore related trials

Alzheimer's Disease

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

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

Who to contact

gamma wave
[email protected]
617-258-7723
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject is between the ages of 65 - 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.
Able to complete the 1st month of at home stimulation at their primary residence. If subjects plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the research team.

Exclusion

Subjects who do not have healthcare.
Subjects who are currently taking amyloid reducing therapy.
Subjects who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose for greater than or equal to three months is ok).
Subjects who are actively diagnosed with cancer and undergoing cancer-related treatments
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
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.
Subjects with untreated or unstable depression
Active treatment with one or more anti-epileptic agent.
Subjects who have had a stroke within the past 24 months.
Subjects who have had eye surgery in the last 3 months or are scheduled to have eye surgery in the next 6 months (during the study)
Subjects diagnosed with migraine headache.
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.
Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous neurosurgery or head trauma that resulted in residual neurologic impairment.

What this trial measures

  • Feasibility of gamma frequency stimulation as assessed by a change of gamma frequency waves during EEGImmediately after completing the stimulation at baseline, month 3, and month 6 visits

    Feasibility of gamma frequency stimulation in subjects with AD will be assessed by analyzing the EEG data from each subject as they undergo gamma light, sound, and tactile stimulation. Investigators will look for a sign of change in gamma frequency waves and determine the percent of subjects who show this change. This change will be assessed through FFT analyses on the EEG data in MATLAB, which looks at the different frequencies that were present during the EEG session.

  • Baseline incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnairesImmediately after the completion of the stimulation at baseline.

    Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects. Subjects will be asked specifically about headaches, light headedness, nausea, dizziness, dry eye, eye strain, light sensitivity, ringing in ears, and any other symptoms they are experiencing.

  • Mid-point incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnairesImmediately after the completion of the stimulation at Month 3.

    Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects. Subjects will be asked specifically about headaches, light headedness, nausea, dizziness, dry eye, eye strain, light sensitivity, ringing in ears, and any other symptoms they are experiencing.

  • Endpoint incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnairesImmediately after the completion of the stimulation at the end of the trial- Month 6 timepoints.

    Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects. Subjects will be asked specifically about headaches, light headedness, nausea, dizziness, dry eye, eye strain, light sensitivity, ringing in ears, and any other symptoms they are experiencing.

  • Change in stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnairesDuring weekly phone calls throughout the 6-month trial period

    Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects. Subjects will be asked specifically about headaches, light headedness, nausea, dizziness, dry eye, eye strain, light sensitivity, ringing in ears, and any other symptoms they are experiencing.

  • Changes in functional brain connectivity as measured by changes in brain white matter on functional MRI scansAt baseline, month 3, and month 6 visits during MRI sessions

    Exploratory measure to check if there are changes in functional brain connectivity after 6 months of daily treatment with the light and sound device. Diffusion tensor imaging (DTI) will be used to test the connectivity and blood flow of the brain by identifying major white matter tracts. This data will be collected at baseline, month 3, and month 6 for each subject, and change will be determined by comparing these timepoints.

  • Changes in functional brain connectivity as measured by changes in blood-oxygen-level-dependent (BOLD) signals on functional MRI scansAt baseline, month 3, and month 6 visits during MRI sessions

    Exploratory measure to check if there are changes in functional brain connectivity after 6 months of daily treatment with the light and sound device. BOLD (blood-oxygen-level-dependent) imaging will be used to determine how regions are communicating and activating together via blood flow. This data will be collected at baseline, month 3, and month 6 for each subject, and change will be determined by comparing these timepoints.

  • Changes in gamma entrainment, as measured by the change in response to 40Hz frequency during EEG sessionsAt baseline, month 3, and month 6 visits during EEG sessions

    Exploratory measure to check if there are changes in gamma entrainment after months of daily treatment with the light and sound device. Gamma entrainment during light and sound stimulation will also be assessed using EEG and FFT analyses in MATLAB to determine the degree to which the brain is responding to the 40hz frequency. This data will be collected at baseline, month 3, and month 6 for each subject, and change will be determined by comparing these timepoints.

  • Changes in molecular biomarkers in AD as measured by RNA sequencing data, particularly those related to inflammation and amyloid levelsImmediately after blood draw at baseline and month 6 visits

    Exploratory measure to check if there are changes in molecular biomarkers of AD (based on RNA sequencing data) as a result of 6 months of daily treatment with the light and sound device. RNA information will be extracted from subjects' blood samples at the baseline and month 6 visits. RNA sequencing of this blood is included based on previous transcriptomic analysis of peripheral leukocytes that showed that inflammation-related genes are related to neurodegenerative disease such as AD. Change will be determined by comparing RNA sequencing data between baseline and month 6 (the beginning and end of the trial).