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
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Device: GENUS device (Active Settings) Device: GENUS device (Sham Settings)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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|
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.
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.
- 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.
- 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.
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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|
- 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.
- 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.
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
|United States, Massachusetts|
|Massachusetts Institute of Technology|
|Cambridge, Massachusetts, United States, 02139|
|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|
|Responsible Party:||Massachusetts Institute of Technology|
|Other Study ID Numbers:||
|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|
|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|
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