Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients

Обзор

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.

Вмешательства

• Поведенческое Phoneme sequence learning
  Approximately half of subjects enrolled in the study will participate in this intervention. Subjects will read aloud monosyllabic sequences that are presented orthographically on a screen. Each sequence is formed by a non-native consonant cluster followed by a vowel and final consonant (CCVC). Speech trials will be grouped into blocks. After a Familiarization block, subjects will produce a set of twelve CCVCs in a Pretest block. Subjects will then repeatedly produce two of those CCVCs in one Tr
• Другое Cessation and re-enabling of stimulation of the STN
  20 adults with Parkinson's disease (PD) who have deep brain stimulator (DBS) implants in the subthalamic nucleus (STN). Stimulation of the STN will be intermittently turned off while subjects complete speech sequence learning tasks. After no more than 35 minutes, stimulation will be re-enabled with normal clinical parameters for each participant.
• Другое Cessation and re-enabling of stimulation of the VIM thalamic nucleus
  20 adults with essential tremor who have deep brain stimulator (DBS) implants in the ventral intermediate nucleus (VIM) of the thalamus will participate in this intervention. Stimulation of the VIM will be intermittently turned off (DBS OFF state) while subjects complete speech sequence learning tasks. After no more than 35 minutes, stimulation will be re-enabled with normal clinical parameters for each participant.
• Поведенческое Multisyllabic sequence learning
  Approximately half of subjects enrolled in the study will participate in this intervention. Subjects will read aloud sequences that are presented orthographically on a screen. Speech trials will be grouped into blocks. After a Familiarization block, subjects will produce 2- and 7-syllable sequences in an Assessment block to determine the appropriate length sequence for the remainder of the intervention. Subjects will produce a set of eight sequences in a Pretest block. Subjects will then repeat

Первичные конечные точки

• Change in speech sequencing accuracy [Срок оценки: Day 1]
• Speech production duration [Срок оценки: Day 1]
• Beta power during speech production [Срок оценки: Day 1]

Вторичные конечные точки (4)

• Cognitive Assessment [Срок оценки: Baseline]
• Forward Digit Span [Срок оценки: Baseline]
• Essential tremor severity [Срок оценки: Day 1]
• Parkinson's disease severity [Срок оценки: Day 1]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 2 центра

• Boston University — Boston
• Massachusetts General Hospital — Boston

Идентификаторы

NCT: NCT07455760 · Guenther_8238 · R01DC022949

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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