AphasiaNCT07460037
Chinese-Specific Speech Imagery Coding Using High-Density ECoG
A study testing Intraoperative high-density ECoG recording and Permanent high-density ECoG implantation in people with Aphasia and Dysarthria, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Aphasia, Dysarthria, ALS
- What is being tested?
- Intraoperative high-density ECoG recording and Permanent high-density ECoG implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 11Show fewer
- 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, middle frontal gyrus, and inferior frontal 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 comprehension ≥80% of normal levels.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Feng Yan, MD, PhD, +86 19032580606, yan.feng7@163.com
About this study
Official title: Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography
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:
Read more
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
- Aphasia, Dysarthria, ALS, Speech and Language Disorder, Stroke, Brain Tumor Adult
- Being tested
- Intraoperative high-density ECoG recording, Permanent high-density ECoG implantation
- Keywords
- speech imagery, speech production, Chinese Mandarin, neural encoding, speech decoding
- Medical subject headings
- Aphasia, Dysarthria, Speech, Language Disorders, Stroke, Epilepsy, Locked-In Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative high-density ECoG recordingProcedure or surgery
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 implantationProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Intraoperative high-density ECoG temporary coverage | Experimental | 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. Receives: Procedure: Intraoperative high-density ECoG recording |
| Permanent high-density ECoG implantation | Experimental | 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. Receives: Procedure: Intraoperative high-density ECoG recording; Procedure: Permanent high-density ECoG implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: through study completion, an average of 2 years
Secondary outcomes (1)
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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Yan, Principal investigator, Department of Neurosurgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460037
- Sponsor's protocol ID
- 2025-1259
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The human patient data relevant to this study are accessible under restricted access according to our IRB protocol.
Publications
Metzger SL, Littlejohn KT, Silva AB, Moses DA, Seaton MP, Wang R, Dougherty ME, Liu JR, Wu P, Berger MA, Zhuravleva I, Tu-Chan A, Ganguly K, Anumanchipalli GK, Chang EF. A high-performance neuroprosthesis for speech decoding and avatar control. Nature. 2023 Aug;620(7976):1037-1046. doi: 10.1038/s41586-023-06443-4. Epub 2023 Aug 23.
PubMed 37612505Lu J, Li Y, Zhao Z, Liu Y, Zhu Y, Mao Y, Wu J, Chang EF. Neural control of lexical tone production in human laryngeal motor cortex. Nat Commun. 2023 Oct 30;14(1):6917. doi: 10.1038/s41467-023-42175-9.
PubMed 37903780Liu Y, Zhao Z, Xu M, Yu H, Zhu Y, Zhang J, Bu L, Zhang X, Lu J, Li Y, Ming D, Wu J. Decoding and synthesizing tonal language speech from brain activity. Sci Adv. 2023 Jun 9;9(23):eadh0478. doi: 10.1126/sciadv.adh0478. Epub 2023 Jun 9.
PubMed 37294753
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Chinese-Specific Speech Imagery Encoding and Decoding Using High-Density Electrocorticography
- ClinicalTrials.gov ID
- NCT07460037
- Acronym / sponsor ID
- 2025-1259
- Conditions
- Aphasia, Dysarthria, ALS, Speech and Language Disorder, Stroke, Brain Tumor Adult
- Keywords
- speech imagery, speech production, Chinese Mandarin, neural encoding, speech decoding
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraoperative high-density ECoG temporary coverage | Experimental | Procedure: Intraoperative high-density ECoG recordingApproximately 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. |
| Permanent high-density ECoG implantation | Experimental | Procedure: Intraoperative high-density ECoG recording, Procedure: Permanent high-density ECoG implantationApproximately 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative high-density ECoG recordingElectrode 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. | Procedure or surgery | Intraoperative high-density ECoG temporary coverage, Permanent high-density ECoG implantation |
| Permanent high-density ECoG implantationIn 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. | Procedure or surgery | Permanent high-density ECoG implantation |
Primary outcome
Electrode Signal Quality Assessment
Time frame: through study completion, an average of 2 years
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.
Decoding Classification Accuracy
Time frame: through study completion, an average of 2 years
The proportion of correctly classified targets by the decoding model is evaluated for recognition categories (e.g., syllables, words, or sentences).
1 secondary outcome
Encoding Model Analysis
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 37612505Metzger SL, Littlejohn KT, Silva AB, Moses DA, Seaton MP, Wang R, Dougherty ME, Liu JR, Wu P, Berger MA, Zhuravleva I, Tu-Chan A, Ganguly K, Anumanchipalli GK, Chang EF. A high-performance neuroprosthesis for speech decoding and avatar control. Nature. 2023 Aug;620(7976):1037-1046. doi: 10.1038/s41586-023-06443-4. Epub 2023 Aug 23.
- Background: PubMed 37903780Lu J, Li Y, Zhao Z, Liu Y, Zhu Y, Mao Y, Wu J, Chang EF. Neural control of lexical tone production in human laryngeal motor cortex. Nat Commun. 2023 Oct 30;14(1):6917. doi: 10.1038/s41467-023-42175-9.
- Background: PubMed 37294753Liu Y, Zhao Z, Xu M, Yu H, Zhu Y, Zhang J, Bu L, Zhang X, Lu J, Li Y, Ming D, Wu J. Decoding and synthesizing tonal language speech from brain activity. Sci Adv. 2023 Jun 9;9(23):eadh0478. doi: 10.1126/sciadv.adh0478. Epub 2023 Jun 9.
- Individual participant dataSharing planned: No. The human patient data relevant to this study are accessible under restricted access according to our IRB protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Feng Yan principal investigator
Department of Neurosurgery, Second Affiliated Hospital, School of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative high-density ECoG recording and Permanent high-density ECoG implantation in people with Aphasia and Dysarthria, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng Yan, MD, PhD (+86 19032580606, yan.feng7@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrode Signal Quality Assessment (time frame: through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460037, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.