Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients (NCT07455760) | Clinical Trial Compass
RecruitingNot Applicable
Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
United States80 participantsStarted 2026-02-18
Plain-language summary
This study will examine how two important brain circuits - one involving the subthalamic nucleus (STN) and one involving the ventral intermediate nucleus of the thalamus (VIM) - contribute to learning and producing speech sequences. Participants will include two groups: 1. individuals with Parkinson's disease who have deep brain stimulation (DBS) devices targeting the STN and 2. individuals with essential tremor who have DBS devices targeting the VIM.
Participants will complete speech tasks involving the learning and repetition of novel sound sequences. During some parts of the study, DBS stimulation will be temporarily turned on or off in a controlled research setting. This will allow researchers to examine how stimulation affects both the learning of new speech sequences and the production of previously learned sequences. All STN participants and most VIM participants will also be equipped with a cutting-edge DBS system, the Percept PC, which will enable the recording of deep brain activity during the tasks.
The results of this study will improve our understanding of how different brain circuits support speech learning and production. In particular, this study will help to differentiate the roles of the STN and VIM in learning the ordering of speech sounds within a syllable from learning of speech sequences containing multiple syllables. This knowledge may help guide future approaches to optimizing DBS settings to improve both movement and speech outcomes in individuals with neurological disorders, as well as provide greater general insight into how these brain structures contribute to speech production and learning.
Who can participate
Age range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Native speakers of American English
* Adults at least 18 years of age
* A clinically established diagnosis of Parkinson's disease or essential tremor
* Able to provide informed consent in the judgment of the investigator
* Treated with deep brain stimulation of the subthalamic nucleus (Parkinson's disease) or ventral intermediate nucleus of the thalamus (essential tremor)
* Stable Parkinson's disease or essential tremor medication regimen for at least one month
* Stable DBS program settings for at least one month
* Nominal DBS system function, including normal impedances at therapeutic DBS contacts, and adequate battery life or adequate IPG charging status for therapy
* For DBS sensing, implanted with Medtronic Percept PC or Percept RC implantable pulse generator
* Corrected vision adequate to easily read text presented during speech motor task
Exclusion Criteria:
* Cognitive impairment (Montreal Cognitive Assessment (MoCA; Nesreddine et al., 2005) score \< 25) or active psychotic or behavioral symptoms that would, in the judgment of the investigator, preclude proper participation in the study
* Hearing impairment that interferes with accurate perception of the speech motor learning stimulus (25dB hearing level threshold at 500, 1k, 2k, and 4kHz frequencies)
* Language impairment (aphasia) or speech articulation impairment (dysarthria) that precludes performance of the speech motor learning task
* Neurological disorder that interferes with speech moto…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.