Investigating Subcortical Contributions to Speech Sequencing in Deep Brain Stimulator Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in speech sequencing accuracy
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Subthalamic nucleus with subsyllabic learning arm
Arm 1: subjects with implanted STN deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
干预措施: Phoneme sequence learning (Behavioral)
Subthalamic nucleus with subsyllabic learning arm
Arm 1: subjects with implanted STN deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
干预措施: Cessation and re-enabling of stimulation of the STN (Other)
Subthalamic nucleus with multisyllabic learning arm
Arm 2: subjects with implanted STN deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
干预措施: Cessation and re-enabling of stimulation of the STN (Other)
Subthalamic nucleus with multisyllabic learning arm
Arm 2: subjects with implanted STN deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
干预措施: Multisyllabic sequence learning (Behavioral)
Ventral intermediate thalamus with subsyllabic learning arm
Arm 3: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
干预措施: Phoneme sequence learning (Behavioral)
Ventral intermediate thalamus with subsyllabic learning arm
Arm 3: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving non-English sound sequences while their stimulators are turned on and off
干预措施: Cessation and re-enabling of stimulation of the VIM thalamic nucleus (Other)
Ventral intermediate thalamus with multisyllabic learning arm
Arm 4: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
干预措施: Cessation and re-enabling of stimulation of the VIM thalamic nucleus (Other)
Ventral intermediate thalamus with multisyllabic learning arm
Arm 4: subjects with implanted VIM deep brain stimulators will undergo learning tasks involving syllable sequences while their stimulators are turned on and off
干预措施: Multisyllabic sequence learning (Behavioral)
结局指标
主要结局
Change in speech sequencing accuracy
时间窗: Day 1
Investigators will evaluate recordings of speech productions to identify errors. This will be used to compare sequence accuracy before and after practice of novel sequences with DBS in the ON and OFF states.
Speech production duration
时间窗: Day 1
Investigators will inspect recordings of speech productions to identify production duration. This will be used to test hypotheses regarding differences in sequence duration before and after practice of novel sequences and with DBS in the ON and OFF states.
Beta power during speech production
时间窗: Day 1
Investigators will extract beta band (12-20 Hz) power from neural recordings taken while subjects practice and rehearse novel speech sequences. This will be used to test hypotheses regarding differences in beta power before and after practice of novel sequences and with DBS in the ON and OFF states.
次要结局
- Forward Digit Span(Baseline)
- Cognitive Assessment(Baseline)
- Essential tremor severity(Day 1)
- Parkinson's disease severity(Day 1)
研究者
Frank Guenther
Professor
Boston University Charles River Campus