Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Electrode Signal Quality Assessment
研究概览
简要总结
The goal of this study is to investigate whether high-density electrocorticography (ECoG) signals recorded from the surface of the brain can be used to decode neural representations of Mandarin Chinese speech features, including lexical tone, without requiring overt speech movements. The study focuses on the development and evaluation of decoding algorithms based on neural activity recorded during clinically indicated neurosurgical procedures.
The main questions it aims to answer are:
Can high-density ECoG signals be decoded to reconstruct neural representations of Mandarin Chinese speech features, particularly lexical tone?
Can neural activity recorded during silent auditory speech imagery be decoded to reconstruct tone-specific speech representations without actual articulation?
The study includes two groups of adult patients with neurological conditions who require cortical electrode placement as part of clinically indicated care:
A intraoperative high-density ECoG temporary coverage group, enrolling approximately 50 patients with functional-area glioma or drug-resistant epilepsy who undergo awake neurosurgery with temporary high-density ECoG coverage for clinical functional mapping.
A permanent high-density ECoG implantation group, enrolling approximately 10 patients with severe speech or language impairment caused by neurological conditions such as stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome, who receive permanent high-density cortical electrode implantation for long-term monitoring.
Participants will:
Complete preoperative clinical assessments as part of standard medical care, including brain imaging, language function evaluation, and routine neurological assessments
Undergo clinically indicated awake neurosurgical procedures during which high-density ECoG electrodes are placed on the cortical surface for clinical functional localization
Perform language-related tasks, such as listening to speech, imagining speech, and limited spoken responses, while brain electrical activity is recorded for approximately 20-30 minutes during surgery, without altering standard surgical procedures
For participants in the permanent implantation group, participate in long-term follow-up visits approximately every 2 weeks or monthly for up to 12 months after surgery, including evaluation of signal quality and research-related analysis and optimization of decoding algorithms
All surgical procedures involving temporary or permanent electrode placement are performed for clinical indications and have been approved through institutional ethical and scientific review. Participation in this study does not alter standard clinical care for the temporary recording group and does not require additional clinical procedures beyond routine treatment.
This research aims to support the long-term development of silent brain-to-speech communication technologies for individuals with severe speech or motor impairments and to improve understanding of how frontal, parietal, and temporal brain regions represent imagined speech in tonal languages such as Mandarin Chinese.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 80 years.
- •Ability and willingness to provide informed consent and comply with study procedures.
- •No severe preoperative emotional or consciousness disorders that would preclude participation in experimental tasks.
- •For patients undergoing intraoperative temporary high-density ECoG coverage: Patients with cerebral eloquent-area gliomas or refractory epilepsy undergoing awake craniotomy as part of standard clinical management.
- •For patients undergoing intraoperative temporary high-density ECoG coverage: Lesions involving or adjacent to eloquent brain areas including language, motor, or memory-related regions.
- •For patients undergoing intraoperative temporary high-density ECoG coverage: Mild mass effect without severe intracranial hypertension.
- •For patients undergoing intraoperative temporary high-density ECoG coverage: Preoperative language function largely preserved, with naming, reading, and language comprehension ≥80% of normal performance.
- •For patients undergoing permanent high-density ECoG implantation: Severe speech or language dysfunction caused by stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome.
- •For patients undergoing permanent high-density ECoG implantation: No substantial improvement after 3-6 months of adequate rehabilitation and disease duration >12 months.
- •For patients undergoing permanent high-density ECoG implantation: Structural integrity of speech imagery-related cortices (ventral central lobule, supramarginal gyrus, superior temporal gyrus, middle temporal gyrus, middle frontal gyrus, and inferior frontal gyrus).
- •For patients undergoing permanent high-density ECoG implantation: Diagnosis of severe dysarthria or severe motor aphasia, with spontaneous speech score <5/20 on the Aphasia Battery of Chinese (ABC) and auditory comprehension ≥80% of normal levels.
排除标准
- •Significant mass effect with severe intracranial hypertension precluding awake craniotomy or electrode implantation.
- •Severe neurological dysfunction that would prevent participation in study procedures (except for speech or language impairment in the permanent implantation cohort).
- •Contraindications to MRI scanning or awake craniotomy, including incompatible implanted medical devices, severe claustrophobia, or obstructive sleep apnea syndrome.
- •Severe psychiatric disorders or cognitive impairment preventing participation in treatment or follow-up assessments (Mini-Mental State Examination score <24).
- •Severe systemic medical comorbidities.
- •Pregnancy or lactation.
- •Refusal or inability to provide informed consent.
研究组 & 干预措施
Intraoperative high-density ECoG temporary coverage
Approximately 50 patients with cerebral eloquent area gliomas or refractory epilepsy will be enrolled. All enrolled patients will undergo awake craniotomy as part of their routine tumor treatment. ① Age between 20 and 80 years; ② Patients with cerebral eloquent area gliomas or refractory epilepsy, with lesions involving or adjacent to eloquent brain areas including language, motor, and memory critical regions; ③ Mild mass effect; ④ No severe language, emotional, or consciousness disorders preoperatively; preoperative language function assessments including naming, reading, and language comprehension abilities must reach 80% of normal levels; ⑤ Informed consent; subjects must demonstrate good willingness and capacity for cooperation.
干预措施: Intraoperative high-density ECoG recording (Procedure)
Permanent high-density ECoG implantation
Approximately 10 patients with speech or language dysfunction resulting from stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome will be enrolled. ① Age between 20 and 80 years; ② Speech or language dysfunction caused by stroke, brain tumors, ALS, or locked-in syndrome, with no substantial improvement after 3-6 months of adequate rehabilitation training and disease duration >12 months; ③ Speech imagery-related cortices (ventral central lobule, supramarginal gyrus, superior temporal gyrus, middle temporal gyrus, middle frontal gyrus, and inferior frontal gyrus) essentially intact; ④ No emotional or consciousness disorders preoperatively; preoperative language assessment diagnosis of severe dysarthria or severe motor aphasia (Aphasia Battery of Chinese, ABC spontaneous speech score <5/20), with auditory comprehension reaching >80% of normal levels; ⑤ Informed consent; subjects must demonstrate good willingness and capacity for cooperation.
干预措施: Intraoperative high-density ECoG recording (Procedure)
Permanent high-density ECoG implantation
Approximately 10 patients with speech or language dysfunction resulting from stroke, brain tumors, amyotrophic lateral sclerosis (ALS), or locked-in syndrome will be enrolled. ① Age between 20 and 80 years; ② Speech or language dysfunction caused by stroke, brain tumors, ALS, or locked-in syndrome, with no substantial improvement after 3-6 months of adequate rehabilitation training and disease duration >12 months; ③ Speech imagery-related cortices (ventral central lobule, supramarginal gyrus, superior temporal gyrus, middle temporal gyrus, middle frontal gyrus, and inferior frontal gyrus) essentially intact; ④ No emotional or consciousness disorders preoperatively; preoperative language assessment diagnosis of severe dysarthria or severe motor aphasia (Aphasia Battery of Chinese, ABC spontaneous speech score <5/20), with auditory comprehension reaching >80% of normal levels; ⑤ Informed consent; subjects must demonstrate good willingness and capacity for cooperation.
干预措施: Permanent high-density ECoG implantation (Procedure)
结局指标
主要结局
Electrode Signal Quality Assessment
时间窗: through study completion, an average of 2 years
Electrode reliability over time is evaluated through electrode impedance, signal-to-noise ratio (SNR), and responsive channel proportion. Low electrode impedance, high SNR, and high responsive channel proportion indicate good signal quality reliability of the device.
Decoding Classification Accuracy
时间窗: through study completion, an average of 2 years
The proportion of correctly classified targets by the decoding model is evaluated for recognition categories (e.g., syllables, words, or sentences).
次要结局
- Encoding Model Analysis(through study completion, an average of 2 years)