Improve speech sequencing using stimulation
- Trial ID
- NCT07455760
- Official Title
- Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
- Goal
- Improve speech sequencing using stimulation
- Phase
- NA
- Status
- RECRUITING
- Sponsor
- Boston University Charles River Campus
- Study Type
- INTERVENTIONAL
- Enrollment
- 80 participants
- Conditions
- Parkinson's Disease (PD), Essential Tremor
- Interventions
- Phoneme sequence learning, Cessation and re-enabling of stimulation of the STN, Cessation and re-enabling of stimulation of the VIM thalamic nucleus, Multisyllabic sequence learning
Summary For Families
The goal is to figure out how the subthalamic and thalamic targets of deep brain stimulation help sequence sounds and syllables, so we can better understand why some people have speech problems with Parkinson's or essential tremor. Participants do phoneme and multisyllabic sequence learning tasks while researchers briefly stop and then re-enable stimulation of the subthalamic nucleus for Parkinson's or the ventral intermediate thalamus for essential tremor, and they record brain activity from Medtronic Percept implantable devices to link stimulation state with speech performance. Briefly stopping stimulation reduces the modulatory input those targets provide, which reveals their role in speech sequencing, and the study does not change your medication regimen. Eligible volunteers are native American English speakers age 18 or older with clinically established Parkinson's disease or essential tremor, stable meds and DBS settings for at least a month, a working STN or VIM DBS system with a Medtronic Percept PC or RC for sensing, intact hearing and cognition (MoCA ≥25), and the ability to tolerate short periods with DBS off; a few language backgrounds are excluded from one sub-study.
Locations
- Boston University, Boston, Massachusetts, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Phoneme sequence learning. The goal is to figure out how the subthalamic and thalamic targets of deep brain stimulation help sequence sounds and syllables, so we can better understand why some people have speech problems with Parkinson's or essential tremor. Participants do phoneme and multisyllabic sequence learning tasks while researchers briefly stop and then re-enable stimulation of the subthalamic nucleus for Parkinson's or the ventral intermediate thalamus for essential tremor, and they record brain activity from Medtronic Percept implantable devices to link stimulation state with speech performance. Briefly stopping stimulation reduces the modulatory input those targets provide, which reveals their role in speech sequencing, and the study does not change your medication regimen. Eligible volunteers are native American English speakers age 18 or older with clinically established Parkinson's disease or essential tremor, stable meds and DBS settings for at least a month, a working STN or VIM DBS system with a Medtronic Percept PC or RC for sensing, intact hearing and cognition (MoCA ≥25), and the ability to tolerate short periods with DBS off; a few language backgrounds are excluded from one sub-study.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- 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 4 years and 5 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.