NCT05268887

High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease

Recruiting
NAAges 45–90InterventionalSupportive care
Massachusetts Institute of Technology
~40 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:GENUS device (Active Settings)GENUS device (Sham settings)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of gamma frequency stimulation
Measured over Immediately after completing the stimulation
+1 more outcome measured
Parkinson Disease

NCT05268887

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts Institute of Technology

    Cambridge, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Li-Huei Tsai, PhD · PRINCIPAL_INVESTIGATOR · Massachusetts Institute of Technology

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity and without any other known or suspected cause of Parkinsonism (according to Movement disorder society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a fellowship trained movements disorder specialist
Subject is Hoehn \& Yahr stage 2 to 3
Subject has a Montreal Cognitive Assessment (MOCA) score ≥26.
Subject is \> 45 and \<90 years of age.
proficient in speaking, reading, and understanding English
capable of providing informed written consent
Subject is on a stable dose (at least 1 month prior to baseline visit) of antiparkinsonian agents and willing to remain on this dose for the duration of the study. If on a cholinesterase inhibitor, a stable dose without changes for 1 month is required.
Subject has undergone a brain CT or MRI prior to rule out underlying structural lesions

Exclusion

Subject has atypical Parkinson's syndrome(s) due to drugs, metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy, Corticobasal Degeneration, Lewy Body dementia)
history of any psychiatric illness that would pose a safety risk
diagnosis of dementia or other neurological conditions
currently taking sedative medications that are clinically contraindicated
has undergone recent change (\<1 month) in medication
recent drug or alcohol abuse or dependence
laboratory results the would pose safety risk
concurrently or has participated in other clinical trial investigation within 3 months
pregnant
no healthcare
history of epilepsy, stroke, or seizure in past 24 months
diagnosis of migraines
have certain implantable medical devices
contraindications for MRI
life expectancy of less than 2 years
  • Feasibility of gamma frequency stimulationImmediately after completing the stimulation

    Feasibility of gamma frequency stimulation in subjects with mild PD 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.

  • Incidence of Stimulation-Related Adverse EventsImmediately after the completion of the stimulation

    Tolerability and safety of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation and denoting any adverse effects.