RECRUITING

Gamma Frequency Stimulation in Individuals With Down Syndrome

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Conditions

Down SyndromeAlzheimer DiseaseNon-Invasive Sensory StimulationLight and Sound StimulationGammaTactile Stimulation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Acute Exposure of Individuals With Down Syndrome to Gamma Frequency Stimulation

Quick Facts

Study Start:2021-12-06
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05196984

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Subject is between the ages of 25-65
  2. * Subject must have a clinically confirmed diagnosis of Down Syndrome (karyotypes optional). Individuals with mosaic Down syndrome will be excluded.
  3. * Subject or their legal guardian is willing to sign informed consent document.
  4. * 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.
  5. * Subject will be medically stable with consistent medication over the previous 3 months.
  1. * Subjects has history of a dual diagnosis Down Syndrome and Autism
  2. * Subjects with has history of seizure or epilepsy within the past 24 months.
  3. * Subjects with a new diagnosis of Attention-deficit/hyperactivity disorder (ADHD) (\< 6 months) or untreated ADHD
  4. * Active treatment with one or more anti-epileptic agent.
  5. * Subjects who have a known history a stroke within the past 24 months.
  6. * Subjects with a known history of migraine headache.
  7. * Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
  8. * Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
  9. * Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
  10. * Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
  11. * 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.
  12. * Subjects who have profound and uncorrected hearing or visual impairment.
  13. * Subjects who are pregnant (self-report).

Contacts and Locations

Study Contact

MJ Quay, MS
CONTACT
6172587723
mcolburn@mit.edu

Principal Investigator

Li-Huei Tsai, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology
Diane Chan, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts Institute of Technology

Study Locations (Sites)

Massachusetts Institute of Technology
Cambridge, Massachusetts, 02139
United States

Collaborators and Investigators

Sponsor: Massachusetts Institute of Technology

  • Li-Huei Tsai, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology
  • Diane Chan, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts Institute of Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-06
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2021-12-06
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Down Syndrome