Deep Brain Stimulation Motor Ventral Thalamus (VOP/VIM) for Restoration of Speech and Upper-limb Function in People With Subcortical Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this study is to verify whether the use of deep brain stimulation can improve motor function of the hand and arm and speech abilities for people following a stroke. Participants will undergo a surgical procedure to implant deep brain stimulation electrode leads. The electrodes will be connected to external stimulators and a series of experiments will be performed to identify the types of movements that the hand and arm can make and how speech abilities are affected by the stimulation. The implant will be removed after less than 30 days. Results of this study will provide the foundation for future studies evaluating the efficacy of a minimally-invasive neuro-technology that can be used in clinical neuro-rehabilitation programs to restore speech and upper limb motor functions in people with subcortical strokes, thereby increasing independence and quality of life.
详细描述
The study is designed to assess the assistive effects of DBS (i.e., immediate effects when the stimulation is turned ON) and obtain preliminary evidence for therapeutic effects (i.e., long-lasting effects with stimulation OFF). Researchers will 1) quantify the ability to recruit face muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, 2) quantify the ability to recruit arm and hand muscles with electrical stimulation of the motor thalamus in patients with subcortical stroke, and 3) verify if the delivery of DBS has effects on the central nervous system with clinical measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must have suffered a single, ischemic, or hemorrhagic stroke more than 6 months before the time of enrollment with dysarthria as a result.
- •Participants must be between the ages of 18 and 75 years old. (Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing).
- •English speaker.
- •Participant must score ≤ 80% in at least 4 categories of the perceptual speech assessment (speech intelligibility, listener effort, speech naturalness, articulatory precision, speech rate, overall voice quality, and/or overall speech severity). OR ≤ 80% in at least 3 categories of the perceptual speech assessment AND ≤ 27 on the Communicative Participation Item Bank.
排除标准
- •Patients who refuse participation in the study.
- •Patients with gross anatomical variances in MR imaging or cerebral vascular accidents involving thalamic and cerebellar areas.
- •Patients with no clinical condition to undergo DBS implantation or highly dependent on anticoagulation therapy.
- •Patients who cannot undergo pre-operative MRIs or could not complete the pre-operative assessments.
- •Participants must not have any serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect their ability to participate in this study.
- •Female participants of child-bearing age must not be pregnant, planning to become pregnant for the next 9 months, or breast feeding.
- •Participants must not be receiving anticoagulants.
- •Severe claustrophobia.
- •Participants must not be on anti-spasticity or anti-epileptic medications for the duration of the study.
- •Participants who have been deemed inappropriate for participation based upon results from the Brief Symptoms Inventory (BSI-18) and discussions with the Principal Investigator and a study physician
- •Evaluation to sign consent form score <
- •MRI contraindications (excluding subjects who are pregnant, who have metal in any portion of their body, have medical complications, cardiac pacemaker, cochlear implant, aneurysm clip, certain IUDs, or known problems of claustrophobia).
- •Medications with common cognitive side-effects.
- •Bleeding disorders or platelet dysfunction (e.g., from regular aspirin usage).
- •Patients must not have any lesions in the lower motoneuron causing flaccid dysarthria.
研究组 & 干预措施
Deep Brain Stimulation of the Motor Thalamus
Individuals who have speech and motor deficits due to a stroke.
干预措施: Deep Brain Stimulation (DBS) of the Motor Thalamus (Device)
结局指标
主要结局
Adverse Events
时间窗: 29 days
The investigators will quantify the safety of DBS to treat post-stroke speech and upper-limb motor deficits. For this, the investigators will record all adverse events for the entire study duration. The study is considered successful if no serious adverse events related to the use of deep brain stimulation are reported.
Discomfort and Pain
时间窗: Baseline, 2 weeks, 4 weeks, 6 months.
The investigators will assess the relative level of discomfort and/or pain that is associated with the delivery of electrical stimulation to the motor thalamus. After each stimulation train patients will be asked to report a level of perceived discomfort using a 10 value subjective scale. Low values will be assigned to low discomfort and high values to high discomfort. The study is considered successful if 70% of recruited subjects do not report discomfort or pain at stimulation amplitudes that are required to obtain motor responses in the face and upper-limb muscles.
次要结局
- Muscle weakness(29 days)
- Dysphagia(29 days)
- Spasticity(29 days)
- Range of Motion (ROM)(29 days)
- Intelligibility of Speech(29 days)
- Hand dexterity(29 days.)
- Dexterity of Articulation AMRs(29 days)
- Dexterity of Articulation SMRs(29 days)
研究者
Jorge Gonzalez-Martinez
Professor
University of Pittsburgh