Phoneme sequence learning for Parkinson's (NCT07455760)
Improve speech sequencing with stimulation
- Trial ID
- NCT07455760
- Official Title
- Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
- Goal
- Improve speech sequencing with 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
Researchers want to understand how two deep brain circuits, the subthalamic nucleus (STN) and the ventral intermediate nucleus of the thalamus (VIM), help people learn and produce sequences of speech sounds, and how that knowledge might help tune deep brain stimulation to improve movement and speech. Adults with Parkinson's who have deep brain stimulation targeting the STN and adults with essential tremor who have stimulation targeting the VIM will practice learning and repeating new sound sequences while their stimulation is briefly turned off and on; many will also wear a Percept PC device that records deep brain activity during the tasks. The tasks compare learning the order of sounds within a single syllable and learning sequences with multiple syllables so researchers can see whether the two brain areas play different roles. The study seeks native American English speakers age 18 and up with a clinical diagnosis of Parkinson's disease or essential tremor, stable medications and stable stimulation settings for at least a month, and the ability to tolerate short changes in stimulation; people with major cognitive or hearing problems that prevent task performance are not eligible.
Locations
- Boston University, Boston, Massachusetts, United States
- Massachusetts General Hospital, Boston, Massachusetts, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07455760. It is the one about "Improve speech sequencing with stimulation". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take?
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Phoneme sequence learning. Researchers want to understand how two deep brain circuits, the subthalamic nucleus (STN) and the ventral intermediate nucleus of the thalamus (VIM), help people learn and produce sequences of speech sounds, and how that knowledge might help tune deep brain stimulation to improve movement and speech. Adults with Parkinson's who have deep brain stimulation targeting the STN and adults with essential tremor who have stimulation targeting the VIM will practice learning and repeating new sound sequences while their stimulation is briefly turned off and on; many will also wear a Percept PC device that records deep brain activity during the tasks. The tasks compare learning the order of sounds within a single syllable and learning sequences with multiple syllables so researchers can see whether the two brain areas play different roles. The study seeks native American English speakers age 18 and up with a clinical diagnosis of Parkinson's disease or essential tremor, stable medications and stable stimulation settings for at least a month, and the ability to tolerate short changes in stimulation; people with major cognitive or hearing problems that prevent task performance are not eligible.
- 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?
- 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 4 years and 5 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Brain surgery / implanted device (invasive). Confirm the full schedule with the study coordinator.