RecruitingNot ApplicableNCT05268887

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

Acute Treatment of Parkinson's Disease With Gamma Frequency Stimulation

Sponsor

Massachusetts Institute of Technology

Enrollment

40 participants

Start Date

Feb 9, 2022

Study Type

INTERVENTIONAL

Conditions

Parkinson Disease

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.

Eligibility

Min Age: 45 YearsMax Age: 90 Years

Inclusion Criteria8

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 Criteria15

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