Recruiting

High Frequency Stimulation

Sponsor:

Massachusetts Institute of Technology

Code:

NCT05268887

Conditions

Parkinson Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

GENUS device (Active Settings)

GENUS device (Sham settings)

Study Details

Brief summary:

Parkinson's disease (PD) impacts different types of neural oscillations in the brain, including beta (13-30Hz) and gamma oscillations (30-80Hz), which contributes to PD's cardinal symptoms of resting tremor, rigidity, bradykinesia (slowness of movement), and gait instability. The investigators' lab has developed a non-invasive method of increasing gamma power in the brain using Gamma Entrainment Using Sensory Stimulation (GENUS) through light, sound, and tactile stimulation devices. For this study, 40 participants with mild Parkinson's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light, sound, and tactile stimulation to determine the safety, feasibility, and optimization of GENUS as a potential therapy in the PD population.

Conditions

Parkinson Disease

Study ID

NCT05268887

Start date

Feb 9, 2022

Status verified date

Mar, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Parkinson's Active Arm

Exposure to active sensory stimulation (40Hz) for 30-60 minutes.

sham comparator: Parkinson's Control Arm

Exposure to control stimulation (sham) for 30-60 minutes.

Interventions

GENUS device (Active Settings)

Participants in the active, experimental group will use the GENUS devices configured to active (40Hz) setting for 30-60 minutes

GENUS device (Sham settings)

Participants in the control group will use the GENUS devices configured to the sham settings for 30-60 minutes

Primary outcome measure

  • Feasibility of gamma frequency stimulation [ Time Frame: Immediately after completing the stimulation ]
  • Incidence of Stimulation-Related Adverse Events [ Time Frame: Immediately after the completion of the stimulation ]

Central Contacts and Locations

Central contacts

gamma wave

617-258-7723gamma.wave@mit.edu

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

Locations

Massachusetts Institute of Technology

Recruiting

Cambridge, Massachusetts, United States, 02139

Contacts

Ana Trisini Lipsanopoulos, BS

617-258-7723anat13@mit.edu

Principal Investigator:

Li-Huei Tsai, PhD

More Information

Sponsor

Massachusetts Institute of Technology

Last update posted

Mar 31, 2026

Last verified

Mar, 2026

Keywords

  • Parkinson's Disease
  • Motor Impairment
  • Non-Invasive Sensory Stimulation
  • Light and Sound Stimulation
  • Tactile Stimulation
  • Gamma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Institute of Technology on 2026-03-31.