Recruiting

Gamma Light & Sound Therapy

Sponsor:

Massachusetts Institute of Technology

Code:

NCT05655195

Conditions

Alzheimer Disease

Alzheimer Disease, Early Onset

Alzheimer Disease, Late Onset

Alzheimer's Disease (Incl Subtypes)

Alzheimer's

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Interventions

GENUS device (Active Settings)

GENUS device (sham settings)

Study Details

Brief summary:

Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. The investigator's lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. The investigators developed a light and sound device for humans that stimulates the brain at 40Hz that can be used safely at home. For the present study, 60 participants with mild Alzheimer's disease will be enrolled and will use this light and sound device at-home daily for 6-months. Investigators will measure changes in brain waves with EEG, blood biomarkers, the microbiome via fecal samples, functional and structural MRI scans, memory and cognitive testing, and questionnaires at 3 in-person visits throughout the study. After the 6-month time point, participants will have the option of continuing in the study for at least one year and completing yearly study visits. This study will provide critical insight into extended therapy involving non-invasive 40Hz sensory stimulation as a possible therapeutic strategy for mild to moderate Alzheimer's disease.

Conditions

Alzheimer Disease

Alzheimer Disease, Early Onset

Alzheimer Disease, Late Onset

Alzheimer's Disease (Incl Subtypes)

Alzheimer's

Study ID

NCT05655195

Start date

Dec 14, 2022

Status verified date

Mar, 2026

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

Subjects may be enrolled into the study if they meet all of the following criteria:

  • 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 Criteria:

Subjects who meet any of the following conditions will not be enrolled in the study:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Alzheimer's Active Arm

Exposure to active sensory stimulation (40Hz) for 60 minutes daily for the length of the trial (6 months).

sham comparator: Alzheimer's Control Arm

Exposure to control stimulation (sham) for 60 minutes daily for the length of the trial (6 months).

Interventions

GENUS device (Active Settings)

Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 60 minutes daily for 6 months.

GENUS device (sham settings)

Participants in the control group will use the GENUS devices configured to the sham settings for 60 minutes daily for 6 months.

Primary outcome measure

  • Feasibility of gamma frequency stimulation as assessed by a change of gamma frequency waves during EEG [ Time Frame: Immediately after completing the stimulation at baseline, month 3, and month 6 visits ]
  • Baseline incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires [ Time Frame: Immediately after the completion of the stimulation at baseline. ]
  • Mid-point incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires [ Time Frame: Immediately after the completion of the stimulation at Month 3. ]
  • Endpoint incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires [ Time Frame: Immediately after the completion of the stimulation at the end of the trial- Month 6 timepoints. ]
  • Change in stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires [ Time Frame: During weekly phone calls throughout the 6-month trial period ]
  • Changes in functional brain connectivity as measured by changes in brain white matter on functional MRI scans [ Time Frame: At baseline, month 3, and month 6 visits during MRI sessions ]
  • Changes in functional brain connectivity as measured by changes in blood-oxygen-level-dependent (BOLD) signals on functional MRI scans [ Time Frame: At baseline, month 3, and month 6 visits during MRI sessions ]
  • Changes in gamma entrainment, as measured by the change in response to 40Hz frequency during EEG sessions [ Time Frame: At baseline, month 3, and month 6 visits during EEG sessions ]
  • Changes in molecular biomarkers in AD as measured by RNA sequencing data, particularly those related to inflammation and amyloid levels [ Time Frame: Immediately after blood draw at baseline and month 6 visits ]

Central Contacts and Locations

Central contacts

gamma wave

617-258-7723gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

Locations

Massachusetts Institute of Technology

Recruiting

Cambridge, Massachusetts, United States, 02142

Contacts

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Mar 30, 2026

Last verified

Mar, 2026

Keywords

  • Alzheimer's
  • Alzheimer
  • Alzheimer's disease
  • Light and Sound Stimulation
  • Tactile Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-03-30.