BridgeMD
New treatment option for Parkinson Disease
Official title High Frequency Light, Sound, and Tactile Stimulation to Improve Motor and Cognitive Deficits in Parkinson's Disease
ClinicalTrials.gov ID: NCT05268887
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 90
You may be able to join if
- Subject has Idiopathic PD defined by the cardinal sign, bradykinesia, plus the presence of at least 1 of the following: resting tremor or rigidity...
- 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
You likely can't join if
- Subject has atypical Parkinson's syndrome(s) due to drugs, metabolic neurogenetic disorders (e.g., Wilson's Disease), encephalitis, cerebrovascular...
- 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
See the full eligibility 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...
- 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...
- Subject has undergone a brain CT or MRI prior to rule out underlying structural lesions
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.