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NCT05196984
Gamma Frequency Stimulation in Individuals With Down Syndrome
NA trial testing GENUS device (Active Settings) in Down Syndrome in 60 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Massachusetts Institute of Technology |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | supportive care |
| Enrollment | 60 |
| Start date | 6 December 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GENUS device (Active Settings)
- GENUS device (Sham Settings)
Conditions studied
- Down Syndrome — all drugs for Down Syndrome →
Sponsor
Massachusetts Institute of Technology
Who can join
Adults 25 to 65, any sex, with Down Syndrome. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Audiovisual gamma stimulation for the treatment of neurodegeneration.
Blanco-Duque C, Chan D, Kahn MC, Murdock MH, et al · · 2024 · cited 42× · PMID 38115692 · DOI 10.1111/joim.13755
Verify or expand the search:
- PubMed search for NCT05196984
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GENUS device (Active Settings)
Trials testing the same drug.
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- NCT04055376 — Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease · NA · active not recruiting
- NCT04042922 — High Frequency Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease · NA · active not recruiting
Other recruiting trials for Down Syndrome
Currently open trials in the same condition.
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- NCT07484464 — Effects of the Otago Exercise Program on Balance, Endurance, and Motor Coordination in Children With Down Syndrome · NA · recruiting
- NCT07428863 — Effects of Jump Rope on Navicular Drop in Down Syndrome · NA · recruiting
- NCT07260136 — Cervical Spine Abnormalities in Down Syndrome · active not recruiting
- NCT07248449 — Physical Fitness in DS: A Comparison of Cuevas Medak and Rebound Exercises · NA · recruiting
Other Massachusetts Institute of Technology trials
Trials by the same sponsor.
- NCT07508722 — Transcranial Ultrasonic Neuromodulation of Primary Visual Cortex and Primary Auditory Cortex in Humans · NA · not yet recruiting
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- NCT06887569 — Using Financial Incentives and Screening to Increase Engagement With Mental Health Services Among College Students in Ch · NA · completed
- NCT06725511 — Wellness Program Outreach and Effectiveness · NA · recruiting
- NCT05964855 — Comparison of Various Prosthetic Foot-Ankle Mechanisms · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05196984 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Massachusetts Institute of Technology
- Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05196984.
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