High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease
Recruiting · NCT05268887 · Interventional (participants receive a specific treatment) · Lead sponsor: Massachusetts Institute of Technology
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Massachusetts Institute of Technology - Cambridge, Massachusetts, United States