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Behavioural Intervention

Gamma Frequency Stimulation for Down Syndrome

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
Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.
Subject is between the ages of 25-65
Must not have
Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
Subjects who have profound and uncorrected hearing or visual impairment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and immediately after the completion of the stimulation

Summary

This trial is testing a non-invasive way to remove toxic proteins from the brain in people with Down Syndrome, which may also improve memory.

Who is the study for?
This trial is for adults aged 25-65 with Down Syndrome, who are medically stable and have not changed medications in the last 3 months. They must be able to give consent or have a guardian do so. Excluded are those with recent strokes, migraines, untreated ADHD, certain medication use (like Wellbutrin), significant psychiatric risks, behavioral issues affecting protocol adherence, active medical implants, severe sensory impairments, pregnancy, autism co-diagnosis or recent seizures.
What is being tested?
The study tests a non-invasive GENUS device that uses light and sound to stimulate the brain. It aims to improve cognitive function by removing toxic proteins associated with Alzheimer's Disease risk in people with Down Syndrome. Participants will undergo EEGs during stimulation sessions to measure brain waves and assess safety and cognitive effects.
What are the potential side effects?
While specific side effects aren't listed for this trial of the GENUS device using tactile vibration stimulation via light and sound; generally such interventions may cause discomfort like headaches or sensory overload but tend to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Down Syndrome, not the mosaic type.
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I am between 25 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am taking medications that may increase my risk of seizures.
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I have severe hearing or vision loss that cannot be corrected.
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I am currently taking medication for a mental health condition.
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I am currently taking medication for epilepsy.
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I have a history of migraine headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after the completion of stimulation
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after the completion of stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acoustic Stimulation
Incidence of Stimulation-Related Adverse Events
Other study objectives
Changes in memory and cognitive performance after gamma frequency stimulation

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Down Syndrome ExperimentalExperimental Treatment1 Intervention
Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Group II: Cognitively Normal ExperimentalExperimental Treatment1 Intervention
Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.
Group III: Down Syndrome ShamPlacebo Group1 Intervention
Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.
Group IV: Cognitively Normal ShamPlacebo Group1 Intervention
Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor
101 Previous Clinical Trials
12,821,965 Total Patients Enrolled
Li-Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology
3 Previous Clinical Trials
135 Total Patients Enrolled
Diane Chan, MD, PhDPrincipal InvestigatorMassachusetts Institute of Technology
2 Previous Clinical Trials
95 Total Patients Enrolled

Media Library

GENUS device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05196984 — N/A
Down Syndrome Research Study Groups: Cognitively Normal Experimental, Down Syndrome Sham, Down Syndrome Experimental, Cognitively Normal Sham
Down Syndrome Clinical Trial 2023: GENUS device Highlights & Side Effects. Trial Name: NCT05196984 — N/A
GENUS device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05196984 — N/A
~7 spots leftby Jun 2025
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