Actively Recruiting

Phase Not Applicable
Age: 20Years - 80Years
All Genders
ID07460037

Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography

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

50

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating whether high-density electrocorticography (ECoG) signals recorded from the brain's surface can decode neural representations of Mandarin Chinese speech features, especially lexical tone, without requiring actual speech movements. The study involves two groups of adult patients with neurological conditions who need cortical electrode placement as part of their clinical care, aiming to support future silent brain-to-speech communication technologies and better understand brain regions involved in imagined speech. The study includes two groups: about 50 patients with brain tumors or drug-resistant epilepsy undergoing awake neurosurgery with temporary high-density ECoG electrode placement, and about 10 patients with severe speech or language impairments due to stroke, brain tumors, ALS, or locked-in syndrome who receive permanent high-density electrode implants for long-term monitoring. During surgery, language tasks are performed while brain signals are recorded, and for the permanent implantation group, long-term follow-up visits occur every 2 weeks or monthly for up to 12 months to assess signal quality and improve decoding algorithms. Participants complete standard preoperative assessments like brain imaging and language evaluations. During surgery, brain activity is recorded for about 20 to 30 minutes while participants listen, imagine, or speak limited words. Those with permanent implants have follow-up visits for up to a year, including signal evaluations and research analysis. The primary outcomes measured include electrode signal quality and decoding accuracy, with secondary analysis of neural encoding during speech imagery, all done alongside routine clinical care without extra procedures for temporary recording patients.

CONDITIONS

Brief 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 prevent participation.
  • For temporary high-density ECoG coverage group: diagnosis of cerebral eloquent-area gliomas or refractory epilepsy undergoing awake craniotomy.
  • For temporary coverage group: lesions involving or adjacent to eloquent brain areas including language, motor, or memory regions.
  • For temporary coverage group: mild mass effect without severe intracranial hypertension.
  • For temporary coverage group: preoperative language function at least 80% of normal performance.
  • For permanent implantation group: severe speech or language dysfunction caused by stroke, brain tumors, ALS, or locked-in syndrome.
  • For permanent implantation group: no significant improvement after 3-6 months of rehabilitation and disease duration over 12 months.
  • For permanent implantation group: structural integrity of speech imagery-related brain areas.
  • For permanent implantation group: severe dysarthria or motor aphasia with spontaneous speech score less than 5/20 and auditory comprehension at least 80% of normal.
Not Eligible

You will not qualify if you...

  • Significant mass effect with severe intracranial hypertension preventing awake craniotomy or electrode placement.
  • Severe neurological dysfunction that blocks participation (except speech/language impairment in permanent group).
  • Contraindications to MRI or awake craniotomy, including incompatible devices, severe claustrophobia, or obstructive sleep apnea.
  • Severe psychiatric disorders or cognitive impairment (Mini-Mental State Examination score less than 24).
  • Severe systemic medical conditions.
  • Pregnancy or breastfeeding.
  • Refusal or inability to provide informed consent.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Surgery

Duration - Surgical day

Participants undergo awake craniotomy with intraoperative high-density ECoG recording including language task assessments and cortical mapping.

1 surgical visit (in-person)

Postoperative Follow-up

Duration - Approximately 13 months

Participants with permanent electrode implantation receive biweekly or monthly follow-up visits for signal quality assessment, neural encoding analysis during speech imagery, and brain-computer interface calibration.

Biweekly or monthly visits for up to 13 months

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

Z

Zehao Zhao, Md, PhD

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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