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New treatment option for Aphasia
Official title Chinese-Specific Speech Imagery Coding Using High-Density ECoG
ClinicalTrials.gov ID: NCT07460037
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 80
You may be able to join if
- 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...
- For patients undergoing intraoperative temporary high-density ECoG coverage: Lesions involving or adjacent to eloquent brain areas including...
You likely can't join if
- 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...
- Contraindications to MRI scanning or awake craniotomy, including incompatible implanted medical devices, severe claustrophobia, or obstructive sleep...
- Severe psychiatric disorders or cognitive impairment preventing participation in treatment or follow-up assessments (Mini-Mental State Examination...
- Severe systemic medical comorbidities.
- Pregnancy or lactation.
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.