Chinese-Specific Speech Imagery Coding Using High-Density ECoG

Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study ID
NCT07460037
Status
Recruiting
Apply to this trial

Conditions

  • ALS
  • Aphasia
  • Brain Tumor Adult
  • Dysarthria
  • Epilepsies
  • Speech and Language Disorder
  • Stroke
  • locked-in Syndrome

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative high-density ECoG recording — PROCEDURE
    Electrode implantation is performed via neurosurgical awake craniotomy. Following intraoperative awakening, direct cortical electrical stimulation is applied to localize language functional areas while the subject performs language tasks. Subsequently, high-density electrocorticography is employed to record neural electrical activity. For the temporary coverage group, this enables precise localization of language functional areas; for the permanent implantation group, this facilitates determination of optimal electrode implantation sites.
  • Permanent high-density ECoG implantation — PROCEDURE
    In the permanent implantation group, subjects demonstrating satisfactory intraoperative electrode signals who voluntarily consent to permanent electrode implantation will undergo permanent electrode placement and long-term follow-up. Postoperative follow-up is conducted biweekly or monthly, encompassing: signal quality assessment, analysis of neural encoding mechanisms during speech imagery, and calibration of brain-computer interface decoding algorithms. The trial duration for each subject is approximately 13 months.

Study Details

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.

Key Dates

Start date
Mar 15, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Electrode Signal Quality Assessment [ Time Frame: through study completion, an average of 2 years ]

Central Contacts

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