Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
NCT07460037

Chinese-Specific Speech Imagery Coding Using High-Density ECoG

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-10

50

Participants Needed

1

Research Sites

146 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Chinese-Specific Speech Imagery Coding Using High-Density ECoG

Who Can Participate

Age: 20Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 temporary high-density ECoG coverage: Patients with cerebral eloquent-area gliomas or refractory epilepsy undergoing awake craniotomy as part of clinical care.
  • For temporary coverage: Lesions involving or near eloquent brain areas including language, motor, or memory regions.
  • For temporary coverage: Mild mass effect without severe intracranial hypertension.
  • For temporary coverage: Preoperative language function largely preserved, with naming, reading, and comprehension at least 80% of normal.
  • For permanent implantation: Severe speech or language dysfunction caused by stroke, brain tumors, ALS, or locked-in syndrome.
  • For permanent implantation: No substantial improvement after 3-6 months of adequate rehabilitation and disease duration over 12 months.
  • For permanent implantation: Structural integrity of speech imagery-related brain cortices.
  • For permanent implantation: Diagnosis of severe dysarthria or motor aphasia with spontaneous speech score under 5/20 and auditory comprehension at least 80% of normal levels.
Not Eligible

You will not qualify if you...

  • Significant mass effect with severe intracranial hypertension preventing awake craniotomy or electrode implantation.
  • Severe neurological dysfunction preventing study participation (except speech or language impairment in permanent group).
  • Contraindications to MRI or awake craniotomy, such as incompatible implants, severe claustrophobia, or obstructive sleep apnea.
  • Severe psychiatric disorders or cognitive impairment preventing treatment or follow-up (MMSE score under 24).
  • Severe systemic medical conditions.
  • Pregnancy or lactation.
  • Refusal or inability to provide informed consent.

AI-Screening

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

F

Feng Yan, MD, PhD

CONTACT

Z

Zehao Zhao, Md, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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Chinese-Specific Speech Imagery Coding Using High-Density ECoG | DecenTrialz