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

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ClinicalTrials.gov Identifier: NCT04042922
Recruitment Status : Active, not recruiting
First Posted : August 2, 2019
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Massachusetts Institute of Technology

Brief 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: GENUS device (Active Settings) Device: GENUS device (Sham Settings) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Official Title: Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
Actual Study Start Date : April 19, 2019
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04042922


Locations
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United States, Massachusetts
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139
Sponsors and Collaborators
Massachusetts Institute of Technology
Investigators
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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:
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Responsible Party: Massachusetts Institute of Technology
ClinicalTrials.gov Identifier: NCT04042922    
Other Study ID Numbers: 1902706647
First Posted: August 2, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Massachusetts Institute of Technology:
Alzheimer Disease
Cognitive Impairment
Non-invasive Sensory Stimulation
Light and Sound Stimulation
Gamma
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders