GENUS device for Parkinson's (NCT05268887)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This trial is estimated to last approximately 5 years and 9 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a sham (a pretend version of the procedure) group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the sham group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain wave recording (EEG) (non-invasive); Wearable / at-home monitoring (non-invasive); Thinking & memory tests (non-invasive). Confirm the full schedule with the study coordinator.