How deep brain stimulation affects learning and producing speech in Parkinson's disease and essential tremor
Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
This research will see if turning deep brain stimulation on and off changes how adults with Parkinson's disease or essential tremor learn and produce new speech sound sequences.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Boston University Charles River Campus Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT07455760 on ClinicalTrials.gov |
What this trial studies
The project compares two groups—people with Parkinson's disease implanted with STN-targeted DBS and people with essential tremor implanted with VIM-targeted DBS—to determine how subcortical circuits contribute to speech sequencing. Participants perform phoneme and multisyllabic sequence learning and repetition tasks while stimulation is systematically turned on and off in controlled sessions. Many participants implanted with the Medtronic Percept device will have deep brain activity recorded during tasks to link stimulation state with neural signals and behavior. The design separates effects on learning new sequences from effects on producing previously learned sequences.
Who should consider this trial
Good fit: Adults (18+) who are native American English speakers with clinically established Parkinson's disease or essential tremor, treated with stable STN-DBS (for PD) or VIM-DBS (for ET), and preferably implanted with a Medtronic Percept device are ideal candidates.
Not a fit: People with cognitive impairment (MoCA < 25), non-native English speakers, unstable DBS or medication regimens, or without Percept-compatible hardware are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, findings could help clinicians tailor DBS programming to reduce speech problems and improve speech learning and production for affected patients.
How similar studies have performed: Prior DBS research has shown stimulation can affect speech, but combining controlled on/off stimulation with chronic Percept recordings to study speech sequencing is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 motor learning * Inability to tolerate symptoms when DBS is off * Orthodontia or atypical oral structure (e.g., cleft palate) that interferes with speech * Pregnancy * For participants in the sub-syllabic sequence learning study (Study C.2.1), experience with the following languages: Hebrew, Polish, Lithuanian, Romanian, Georgian, Tepehua, Hungarian, and Pima
Where this trial is running
Boston, Massachusetts and 1 other locations
- Boston University — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Frank H Guenther, Ph.D. — Boston University
- Study coordinator: Frank H Guenther, Ph.D.
- Email: guenther@bu.edu
- Phone: 617-353-5765
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.