Reduce slowness stiffness and tremor
- Trial ID
- NCT05268887
- Official Title
- Acute Treatment of Parkinson's Disease With Gamma Frequency Stimulation
- Goal
- Reduce slowness stiffness and tremor
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Massachusetts Institute of Technology
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson Disease
- Interventions
- GENUS device (Active Settings), GENUS device (Sham settings)
Summary For Families
It aims to see whether a short session of gamma-frequency brain stimulation can quickly ease motor symptoms like slowness, stiffness, or tremor in people with mid-stage Parkinson's. The approach uses MIT's GENUS device to deliver noninvasive ~40 Hz sensory stimulation that tries to entrain brain rhythms and modulate motor circuits, participants get either active or sham settings so effects can be compared, and everyone stays on their usual antiparkinsonian medicines at a stable dose so the device is tested as an add-on. They are looking for people aged 45 to 90 with idiopathic PD at Hoehn and Yahr stage 2 to 3, MoCA score ≥26, on stable Parkinson's meds for at least a month, and without seizures, migraines, dementia, certain implants, or major psychiatric or other neurological conditions.
Locations
- Massachusetts Institute of Technology, Cambridge, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying GENUS device (Active Settings). It aims to see whether a short session of gamma-frequency brain stimulation can quickly ease motor symptoms like slowness, stiffness, or tremor in people with mid-stage Parkinson's. The approach uses MIT's GENUS device to deliver noninvasive ~40 Hz sensory stimulation that tries to entrain brain rhythms and modulate motor circuits, participants get either active or sham settings so effects can be compared, and everyone stays on their usual antiparkinsonian medicines at a stable dose so the device is tested as an add-on. They are looking for people aged 45 to 90 with idiopathic PD at Hoehn and Yahr stage 2 to 3, MoCA score ≥26, on stable Parkinson's meds for at least a month, and without seizures, migraines, dementia, certain implants, or major psychiatric or other neurological conditions.
- Who can participate?
- Participants must be between 45 Years and 90 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 9 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.