High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease
- Conditions
- Parkinson Disease
- Registration Number
- NCT05268887
- Lead Sponsor
- Massachusetts Institute of Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the<br> presence of at least 1 of the following: resting tremor or rigidity and without any<br> other known or suspected cause of Parkinsonism (according to Movement disorder<br> society (MDS) clinical diagnostic criteria for Parkinson's disease confirmed by a<br> fellowship trained movements disorder specialist<br><br> - Subject is Hoehn & Yahr stage 2 to 3<br><br> - Subject has a Montreal Cognitive Assessment (MOCA) score =26.<br><br> - Subject is > 45 and <90 years of age.<br><br> - proficient in speaking, reading, and understanding English<br><br> - capable of providing informed written consent<br><br> - Subject is on a stable dose (at least 1 month prior to baseline visit) of<br> antiparkinsonian agents and willing to remain on this dose for the duration of the<br> study. If on a cholinesterase inhibitor, a stable dose without changes for 1 month<br> is required.<br><br> - Subject has undergone a brain CT or MRI prior to rule out underlying structural<br> lesions<br><br>Exclusion criteria:<br><br> - Subject has atypical Parkinson's syndrome(s) due to drugs, metabolic neurogenetic<br> disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular disease, or<br> degenerative disease (e.g., Progressive Supranuclear Palsy, Multiple System Atrophy,<br> Corticobasal Degeneration, Lewy Body dementia)<br><br> - history of any psychiatric illness that would pose a safety risk<br><br> - diagnosis of dementia or other neurological conditions<br><br> - currently taking sedative medications that are clinically contraindicated<br><br> - has undergone recent change (<1 month) in medication<br><br> - recent drug or alcohol abuse or dependence<br><br> - laboratory results the would pose safety risk<br><br> - concurrently or has participated in other clinical trial investigation within 3<br> months<br><br> - pregnant<br><br> - no healthcare<br><br> - history of epilepsy, stroke, or seizure in past 24 months<br><br> - diagnosis of migraines<br><br> - have certain implantable medical devices<br><br> - contraindications for MRI<br><br> - life expectancy of less than 2 years
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility of gamma frequency stimulation;Incidence of Stimulation-Related Adverse Events
- Secondary Outcome Measures
Name Time Method