Status:
RECRUITING
High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease
Lead Sponsor:
Massachusetts Institute of Technology
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-90 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
It is known that Parkinson's disease (PD) patients have disruptions in brain waves, specifically the beta frequency (13 - 30Hz) and gamma frequency (\~30 - 100 Hz), due to the death of dopaminergic ne...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05268887
Start Date
February 9 2022
End Date
November 1 2025
Last Update
December 18 2024
Active Locations (1)
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1
Massachusetts Institute of Technology
Cambridge, Massachusetts, United States, 02139