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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE August 2, 2019
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE April 19, 2019
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 1, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 1, 2019)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease
Official Title  ICMJE Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Supportive Care
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Exposure to active stimulation for 30 - 60 min
    Subjects in this arm will receive 30 - 60 minutes of active stimulation
    Intervention: Device: GENUS device (Active Settings)
  • Sham Comparator: Exposure to control stimulation for 30 - 60 min
    Subjects in this arm will receive 30 - 60 minutes of control stimulation
    Intervention: Device: GENUS device (Sham Settings)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 6, 2020)
80
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2019)
40
Estimated Study Completion Date  ICMJE April 30, 2023
Estimated Primary Completion Date April 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04042922
Other Study ID Numbers  ICMJE 1902706647
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Massachusetts Institute of Technology
Study Sponsor  ICMJE Massachusetts Institute of Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Massachusetts Institute of Technology
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP