Your session is about to expire
← Back to Search
Behavioural Intervention
Gamma Light and Sound Therapy for Alzheimer's Disease
N/A
Recruiting
Led By Li Huei Tsai, PhD
Research Sponsored by Massachusetts Institute of Technology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, month 3, and month 6 visits during mri sessions
Summary
This trial tests a light & sound device that boosts gamma waves to reduce toxic proteins in Alzheimer's patients & improve memory. 50 participants will use it daily for 6-12 months & have in-person visits to measure changes.
Who is the study for?
This trial is for individuals aged 50-100 with mild Alzheimer's disease, having an MMSE score of 19-26. They must be able to give consent or have a representative do so and complete the first month at their primary residence. Excluded are those without healthcare, on certain Alzheimer's medications, unstable psychiatric treatments, seizure history within two years, significant suicide risk, behavioral issues affecting compliance, recent stroke or eye surgery candidates.
What is being tested?
The study tests a device called GENUS that uses light and sound at 40Hz aimed to stimulate brain waves in people with mild Alzheimer's disease. Participants will use this device daily for six months at home while undergoing various assessments including EEGs, MRIs, cognitive tests and questionnaires to evaluate its effects on brain function and memory.
What are the potential side effects?
Since the intervention involves non-invasive sensory stimulation using light and sound rather than medication or invasive procedures, side effects may be minimal but could include discomfort from light or sound exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, month 3, and month 6 visits during mri sessions
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, month 3, and month 6 visits during mri sessions
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Baseline incidence of stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires
Change in stimulation-related adverse symptoms and side effects as assessed by post-stimulation questionnaires
Changes in functional brain connectivity as measured by changes in blood-oxygen-level-dependent (BOLD) signals on functional MRI scans
+6 moreSecondary study objectives
Changes in cognitive performance as assessed by scores on an Alzheimer's cognitive testing battery
Changes in sleep/wake patterns, as measured by actigraph watch analyses
Changes in the microbiome as measured by fecal samples
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Alzheimer's Active ArmActive Control1 Intervention
Exposure to active sensory stimulation (40Hz) for 60 minutes daily for the length of the trial (6 months).
Group II: Alzheimer's Control ArmPlacebo Group1 Intervention
Exposure to control stimulation (sham) for 60 minutes daily for the length of the trial (6 months).
Find a Location
Who is running the clinical trial?
Massachusetts Institute of TechnologyLead Sponsor
98 Previous Clinical Trials
12,819,937 Total Patients Enrolled
Li Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If I can't consent, someone legally allowed will do it for me.I have been diagnosed with migraine.I am between 50 and 100 years old.I have severe hearing or vision loss.I am taking medications that may increase my risk of seizures.I have mild Alzheimer's with a specific cognitive test score.I have had a seizure or been diagnosed with epilepsy in the last 2 years.I am currently on medication to reduce amyloid.I have no neurological disorders except possibly dementia, and no history of serious head injuries or brain surgery.I am currently taking medication for epilepsy.I have been on psychiatric medication for less than 3 months or have been stable on it for 3 months or more.I have had a stroke in the last 2 years.I haven't had eye surgery in the last 3 months and don't plan to in the next 6 months.I am currently taking medication that affects NMDA receptors.
Research Study Groups:
This trial has the following groups:- Group 1: Alzheimer's Active Arm
- Group 2: Alzheimer's Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger