Gamma Frequency Stimulation in Individuals With Down Syndrome

NCT05196984 | Recruiting FDA Device

• 1 other identifier: 1908962521
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Down Syndrome (DS) is characterized by an additional copy of chromosome 21, which also increases risk of Alzheimer's Disease (AD). The investigators' lab found a non-invasive way to remove toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators then translated this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients and cognitively normal adults. The investigators have also translated this research into a vibrating speaker device to study tactile vibration to stimulate the brain as well. For the present study, 30 participants with Down Syndrome and 30 cognitively normal adult controls will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) during light, sound, and tactile stimulation. The investigators will also test for safety, feasibility, and cognitive performance before and after a 30-60 minute session of light and sound stimulation to optimize the stimulation devices for use in the DS population.

Conditions

Down Syndrome

Keywords

Down Syndrome; Alzheimer Disease; Non-Invasive Sensory Stimulation; Light and Sound Stimulation; Gamma; Tactile Stimulation

Outcome Measures

Primary Outcomes (2)

• Feasibility of gamma frequency stimulation

  Feasibility of gamma frequency stimulation in subjects with DS 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.

  Immediately after the completion of stimulation

• Incidence of Stimulation-Related Adverse Events

  Tolerability and safety of gamma frequency stimulation will be assessed using questionnaires and measures to rate the subjects' overall experience with the stimulation. These questionnaires will monitor for any adverse effects of the stimulation.

  Immediately after the completion of stimulation

Other Outcomes (1)

• Changes in memory and cognitive performance after gamma frequency stimulation

  Baseline and immediately after the completion of the stimulation

Study Arms (4)

Down Syndrome Experimental

EXPERIMENTAL

Experimental arm within Down Syndrome participant group: exposure to active 40Hz stimulation for 30-60 minutes.

Device: GENUS device (Active Settings)

Down Syndrome Sham

SHAM COMPARATOR

Sham arm within the Down Syndrome participant group: exposure to control stimulation for 30-60 minutes.

Device: GENUS device (Sham Settings)

Cognitively Normal Experimental

EXPERIMENTAL

Experimental arm within the cognitively normal control participant group: exposure to active 40Hz stimulation for 30-60 minutes.

Device: GENUS device (Active Settings)

Cognitively Normal Sham

SHAM COMPARATOR

Sham arm within the cognitively normal control participant group: exposure to control stimulation for 30-60 minutes.

Device: GENUS device (Sham Settings)

Interventions

GENUS device (Active Settings) DEVICE

Participants in the active condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to active 40Hz settings for 30-60 minutes.

Also known as: Gamma Frequency Stimulation, Light and Sound Stimulation

Cognitively Normal Experimental; Down Syndrome Experimental

GENUS device (Sham Settings) DEVICE

Participants in the control condition within the Down Syndrome participant group and the Cognitively Normal Control group will use the GENUS device configured to sham settings for 30-60 minutes.

Also known as: Gamma Frequency Stimulation, Light and Sound Stimulation

Cognitively Normal Sham; Down Syndrome Sham

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between the ages of 25-65
• Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.
• Subject or their legal guardian 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.
• Subject will be medically stable with consistent medication over the previous 3 months.

You may not qualify if:

• Subjects has history of a dual diagnosis Down Syndrome and Autism
• Subjects with has history of seizure or epilepsy within the past 24 months.
• Subjects with a new diagnosis of Attention-deficit/hyperactivity disorder (ADHD) (\< 6 months) or untreated ADHD
• Active treatment with one or more anti-epileptic agent.
• Subjects who have a known history a stroke within the past 24 months.
• Subjects with a known history of migraine headache.
• Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
• 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 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 and uncorrected hearing or visual impairment.
• Subjects who are pregnant (self-report).

Sponsors & Collaborators

• Massachusetts Institute of Technology: lead

Study Sites (1)

Massachusetts Institute of Technology

Cambridge, Massachusetts, 02139, United States

RECRUITING

Related Publications (2)

• Parker SE, Mai CT, Canfield MA, Rickard R, Wang Y, Meyer RE, Anderson P, Mason CA, Collins JS, Kirby RS, Correa A; National Birth Defects Prevention Network. Updated National Birth Prevalence estimates for selected birth defects in the United States, 2004-2006. Birth Defects Res A Clin Mol Teratol. 2010 Dec;88(12):1008-16. doi: 10.1002/bdra.20735. Epub 2010 Sep 28.

  PMID: 20878909 BACKGROUND

• Pueschel SM. Clinical aspects of Down syndrome from infancy to adulthood. Am J Med Genet Suppl. 1990;7:52-6. doi: 10.1002/ajmg.1320370708.

  PMID: 2149974 BACKGROUND

MeSH Terms

Conditions

Down Syndrome; Alzheimer Disease

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Officials

• Li-Huei Tsai, PhD

  Massachusetts Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gamma wave, BS

CONTACT

6172587723; gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

CONTACT

6172587723; anat13@mit.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: January 19, 2022
• Study Start: December 6, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)