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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 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, month 3, and month 6 visits during mri sessions

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, month 3, and month 6 visits during mri sessions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 more

Secondary outcome measures

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).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor

97 Previous Clinical Trials

12,729,937 Total Patients Enrolled

Li Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology

Media Library

GENUS device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05655195 — N/A

Alzheimer's Disease Research Study Groups: Alzheimer's Active Arm, Alzheimer's Control Arm

Alzheimer's Disease Clinical Trial 2023: GENUS device Highlights & Side Effects. Trial Name: NCT05655195 — N/A

GENUS device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05655195 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants of this study restricted to a particular age range?

"This medical trial has a narrow age range of eligibility, requiring participants to be between 50 and 100 years old. By contrast, there are 23 studies for youth under 18 and 550 trials specifically designed for seniors over 65."

Answered by AI

Are volunteers still required for this research endeavor?

"As per the clinical trial records, this medical research is actively in need of participants. The study was created on December 14th 2022 and last edited eight days later."

Answered by AI

Are there any requirements for those wishing to take part in this research?

"This medical trial is actively seeking 50 individuals with Alzheimer's disease, aged between fifty and one hundred years old. Essential criteria for inclusion include: a Mini Mental State Exam score of 19-26, consent to sign an informed document or the ability to provide surrogate consent if subject lacks capacity, commitment to complete the initial month of home stimulation at their primary residence (unless away from this location for over a week), and falling within the specified age range."

Answered by AI

How many individuals are actively participating in this research endeavor?

"Correct. As per the information housed on clinicaltrials.gov, this medical trial is currently enrolling people and was first posted online on December 14th 2022. The study requires 50 volunteers from 1 location to complete it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy

2022. "Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05655195.

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