Using light, sound, and touch to improve movement and thinking in Parkinson's disease
Acute Treatment of Parkinson's Disease With Gamma Frequency Stimulation
This study is testing a new method using light, sound, and touch to see if it can help people with mild Parkinson's disease move better and think more clearly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 45 Years to 90 Years |
| Sex | All |
| Sponsor | Massachusetts Institute of Technology Academic / other |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT05268887 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 45 to 90 with mild idiopathic Parkinson's disease who have stable symptoms and cognitive function.
Not a fit: Patients with advanced Parkinson's disease or those with significant cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new non-invasive treatment option to improve motor and cognitive deficits in patients with Parkinson's disease.
How similar studies have performed: Previous studies have shown that similar non-invasive stimulation methods can be effective in other populations, suggesting potential for success in this novel application for Parkinson's disease.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cambridge, Massachusetts
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.