Reduce tremor while preserving speech
- Trial ID
- NCT04650932
- Official Title
- Dual Frequency, Dual Region Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease
- Goal
- Reduce tremor while preserving speech
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- University of California, Davis
- Study Type
- INTERVENTIONAL
- Enrollment
- 10 participants
- Conditions
- Parkinson Disease
- Interventions
- Deep brain stimulation
Summary For Families
The goal is to test whether giving different electrical frequencies to the upper and lower parts of the subthalamic nucleus can better control tremor, slowness, and stiffness while reducing cognitive or speech side effects. The approach uses the already-implanted Boston Scientific Vercise DBS system to send targeted pulses to dorsal and ventral STN contacts, changing abnormal brain circuit activity that causes motor symptoms; it does not replace levodopa but can change how well motor control responds and may allow medication adjustments. Looking for adults 18 and older with idiopathic, advanced Parkinson's who already have the Vercise system implanted for at least 3 months with bilateral dorsal STN leads reaching the ventral STN, who can do cognitive testing in English and meet simple MoCA and depression score cutoffs.
Locations
- UC Davis Health, Sacramento, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Deep brain stimulation. The goal is to test whether giving different electrical frequencies to the upper and lower parts of the subthalamic nucleus can better control tremor, slowness, and stiffness while reducing cognitive or speech side effects. The approach uses the already-implanted Boston Scientific Vercise DBS system to send targeted pulses to dorsal and ventral STN contacts, changing abnormal brain circuit activity that causes motor symptoms; it does not replace levodopa but can change how well motor control responds and may allow medication adjustments. Looking for adults 18 and older with idiopathic, advanced Parkinson's who already have the Vercise system implanted for at least 3 months with bilateral dorsal STN leads reaching the ventral STN, who can do cognitive testing in English and meet simple MoCA and depression score cutoffs.
- Who can participate?
- Participants must be at least 18 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 3 years and 8 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.