Using light, sound, and touch to improve movement and thinking in Parkinson's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates a non-invasive method called Gamma Entrainment Using Sensory Stimulation (GENUS) to enhance brain activity in patients with mild Parkinson's disease. By applying light, sound, and tactile stimulation, the researchers aim to boost gamma oscillations in the brain, which may alleviate motor symptoms such as tremors and slowness of movement. The study will involve 40 participants who will undergo electroencephalogram (EEG) assessments before, during, and after stimulation to evaluate the safety and effectiveness of this approach. The goal is to determine if GENUS can serve as a viable therapy for improving motor and cognitive functions in Parkinson's patients.

Why it matters

Who can join: the full rules

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's running

• Massachusetts Institute of Technology
  Cambridge, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Li-Huei Tsai, PhD — Massachusetts Institute of Technology
• Study coordinator: gamma wave
• Email: gamma.wave@mit.edu
• Phone: 617-258-7723

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.