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Official title Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
ClinicalTrials.gov ID: NCT07455760
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Cognitive impairment (Montreal Cognitive Assessment (MoCA; Nesreddine et al., 2005) score \< 25) or active psychotic or behavioral symptoms that...
- Hearing impairment that interferes with accurate perception of the speech motor learning stimulus (25dB hearing level threshold at 500, 1k, 2k, and...
- 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
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.