An interventional study of Intraoperative high-density ECoG recording and Permanent high-density ECoG implantation in Aphasia, Dysarthria and ALS, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Recruiting at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Intraoperative high-density ECoG recording
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.
Procedure: Intraoperative high-density ECoG recording · Procedure: Permanent high-density ECoG implantation
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.
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.
Electrode Signal Quality Assessment
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.
Time frame: through study completion, an average of 2 years
Decoding Classification Accuracy
The proportion of correctly classified targets by the decoding model is evaluated for recognition categories (e.g., syllables, words, or sentences).
Time frame: through study completion, an average of 2 years
Encoding Model Analysis
An L2-regularized time-receptive-field (TRF) model (time window: -400 to 400 ms) with parallel five-fold cross-validation is employed to calculate the coefficient of determination (R²) between neural signals and AKT, phonemic features, and Mel-spectrogram, respectively, enabling comprehensive evaluation of the encoding capacity of fronto-parieto-temporal neurons for articulatory and acoustic features.
Time frame: through study completion, an average of 2 years
Adverse Event Incidence Rate
All adverse events are collected through active monitoring (intraoperative observation, postoperative daily ward rounds), adverse event report forms, imaging examinations, laboratory tests (routine blood test, cerebrospinal fluid analysis), and patient complaints. Incidence rates are calculated separately for each adverse event category (intraoperative electrical stimulation-related, device-related, drug-related, pregnancy-related, etc.) using the formula: number of patients experiencing specific adverse events divided by total enrolled patients multiplied by 100%.
Time frame: through study completion, an average of 2 years
Plan to share: No — The human patient data relevant to this study are accessible under restricted access according to our IRB protocol.
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