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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years to 90 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests light, sound, and touch stimulation in 40 people with mild Parkinson’s disease. Researchers will record brain waves with EEG before, during, and after stimulation to check safety and find the best way to use it as a possible treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have Parkinson’s disease confirmed by a movement specialist, with slow movement plus shaking at rest or stiff muscles, and no other known or suspected cause.
- Have Parkinson’s disease at stage 2 or 3 on the Hoehn and Yahr scale, which rates disease severity.
- Score at least 26 on the Montreal Cognitive Assessment, a test of memory and thinking.
- Be older than 45 and younger than 90.
- Be able to speak, read, and understand English well.
- Be able to understand the study and give written consent.
- Have taken the same dose of Parkinson’s medicines for at least 1 month and agree to keep it during the study. If taking a cholinesterase inhibitor, a medicine for memory and thinking, its dose must also be unchanged for 1 month.
- Have had a brain CT or MRI scan to rule out damage or other problems in the brain’s structure.
Who can't join
- Have Parkinson-like symptoms caused by drugs or another disease, dementia, or another condition affecting the brain or nerves.
- Have a mental health condition or lab test results that could make the study unsafe.
- Take sedating medicines that are unsafe for you, have changed medicines within the past month, or have recent drug or alcohol abuse or dependence.
- Are in another clinical trial now or took part in one within the past 3 months.
- Are pregnant, have no healthcare, or are expected to live less than 2 years.
- Have a history of epilepsy, stroke, or a seizure in the past 24 months.
- Have been diagnosed with migraines.
- Have certain medical devices inside your body or cannot safely have an MRI.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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
Study sites (1)
MA
- Massachusetts Institute of Technology · Cambridge, MA 02139Ana Trisini Lipsanopoulos, BS · Study contact · 617-258-7723 · anat13@mit.eduLi-Huei Tsai, PhD · Principal investigatorUte Geigenmuller, PhD · Sub-investigatorAna Trisini Lipsanopoulos, BS · Sub-investigatorMore trials in Cambridge