Cleft Lip and/or PalatefMRI-Speech-CPNCT07330687
Neural Changes After Speech Therapy in Patients With Cleft Palate: A Brain Imaging Study
A study testing Structured Speech Training for Decompensation in people with Cleft Lip and/or Palate and Speech Disorder, run by Shufan Zhao at 1 site in China.
Trial summary
Cleft palate is one of the most common maxillofacial congenital malformations, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological change among these patients. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and/or Palate, Speech Disorder, Speech Therapy
- What is being tested?
- Structured Speech Training for Decompensation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2019to 21 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 4 and 16 years.
- For patient groups: Diagnosed with non-syndromic cleft palate and having undergone cleft palate repair surgery at least 1 year prior.
- For the NOA group: Diagnosed with compensatory articulation disorder (Non-oral Articulation, NOA) through standardized speech assessment.
- For the OA group: Confirmed to have no compensatory articulation disorder (Oral Articulation, OA) through standardized speech assessment.
- For the healthy control group: No history of any craniofacial malformations, speech disorders, or neurological diseases.
- Participants and their legal guardians are able to understand and willing to provide written informed consent.
- Able to cooperate with and complete magnetic resonance imaging (MRI) examinations (e.g., no claustrophobia, no contraindicated metal implants).
Who cannot join
- Presence of other known syndromes or cognitive impairments (e.g., autism spectrum disorder, intellectual disability).
- History of other neurological diseases that may affect speech function (e.g., cerebral palsy, hearing loss).
- Presence of severe other orofacial anomalies, or an unrepaired palatal fistula.
- Contraindications for MRI examination (e.g., non-removable metal implants, severe claustrophobia).
- Having received systematic speech therapy within the past 6 months.
- Any other condition deemed by the investigator to be unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
School & Hospital of Stomatology Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
Official title: A Brain Imaging Study of Abnormal Neural Network Reorganization Following Speech Training in Patients With Compensatory Articulation Secondary to Cleft Palate
Cleft palate is one of the most common maxillofacial congenital malformations, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological change among these patients. However, the outcome of speech therapy, an important treatment method, for NOA is often unsatisfactory. This is attributed to the erroneous articulation patterns and entrenched habits in patients with NOA, which require considerable training intensity and time. According to preliminary results from the investigators' own study, as well as studies by others, structural and functional changes have been clearly identified in some brain regions of patients with NOA, suggesting that abnormal neural networks are involved in the progression of NOA. Thus, the investigators proposed the hypothesis that speech therapy effectively corrects articulation disorders through reconfiguration of pathological neural function and reorganization of the abnormal neural network involved in NOA. In this study, multimodal brain imaging techniques will be applied to investigate differences in brain functional connectivity and structural connectivity networks among groups with oral articulation (OA), varying degrees of NOA in postoperative cleft palate patients, and healthy controls. The relationship between improvement in speech intelligibility and alterations in brain networks before and after intervention will be compared. This study aims to reveal the neural network substrates associated with NOA and speech therapy. Overall, through this comprehensive study, the investigators aim not only to provide new insight into the underlying neural mechanism of NOA but also to accumulate evidence for improving the efficacy of speech therapy and discovering new therapeutic strategies in clinical practice.
Read the detailed description
Cleft palate often leads to compensatory articulation disorder (Non-oral Articulation, NOA), which is resistant to conventional speech therapy. This study is grounded in the hypothesis that the efficacy of speech training is mediated by the reorganization of pathological neural networks and structures associated with NOA.
This non-randomized, longitudinal study employs a parallel-group design involving three cohorts: patients with NOA receiving speech training, postoperative cleft palate patients with normal oral articulation (OA) as a clinical control, and healthy controls. The primary objective is to identify the distinctive neural signatures (in both functional connectivity and brain structure) linked to NOA and its remediation through training.
All participants undergo multimodal magnetic resonance imaging (including high-resolution T1-weighted and resting-state functional scans) and standardized speech assessments at baseline. Only the NOA group then receives a structured speech training intervention, followed by post-intervention reevaluation. By comparing changes within and between groups, this study aims to disentangle neural alterations specific to NOA from those related to cleft palate in general.
The integrative analysis of brain-wide changes with a focus on speech-related regions is expected to provide a systems-level understanding of the neural mechanisms underlying NOA and treatment-induced recovery. The findings may contribute to the development of more effective, neuroscience-informed therapeutic strategies.
- Conditions
- Cleft Lip and/or Palate, Speech Disorder, Speech Therapy, Brain, Magnetic Resonance Imaging
- Being tested
- Structured Speech Training for Decompensation
- Medical subject headings
- Speech Disorders, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Speech Training for DecompensationBehavioural
This structured, one-on-one speech decompensation therapy targets Non-oral Articulation Disorder (NOA) in postoperative cleft palate patients, using the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits. It follows a structured paradigm from error recognition to generalization, integrating multisensory cues. Delivered by a therapist 3 times/week for 1 hour over 5-12 weeks with parent participation, it includes daily home practice. Completion requires accurate sound production, with daily parent-supervised maintenance practice for one year thereafter.
| Study group | Role | What they receive |
|---|---|---|
| Non-Oral Articulation(NOA) group | Experimental | Participants receive the investigational behavioral intervention: Structured Speech Decompensation Therapy. This one-on-one therapy uses the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits, integrating multisensory cues. The intervention is administered by a certified speech therapist at a dosage of 1-hour sessions, with a frequency of 3 sessions per week, for a duration of 5 to 12 weeks. Parent participation in sessions and daily prescribed home practice are required components. Receives: Behavioral: Structured Speech Training for Decompensation |
| Oral Articulation (OA) Group | No intervention | Participants do not receive the investigational speech training intervention. This arm serves as the clinical control group. |
| healthy control(HC) | No intervention | Participants do not receive any study-related intervention. This arm serves as the healthy normative control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Connectivity of the Speech Related Network
Change in resting-state functional connectivity, focusing on connections between pre-defined speech-related regions (Broca's and Wernicke's areas) and additionally assessed through whole-brain network analysis, using resting-state fMRI data.
Measured: From baseline assessment to post-training assessment (approximately at Week 12)
Change in Percent Correct Consonants (PCC)
Change in the percentage of consonants produced correctly, assessed within both single-word and conversational speech contexts. The measure is derived from standardized speech samples, which are evaluated by blinded, certified speech-language pathologists.
Measured: From baseline assessment to post-training assessment (approximately at Week 12)
Secondary outcomes (5)
Change in Grey Matter Volume (GMV) of Articulation-Related Regions
Alterations in grey matter volume across the whole brain, with a focus on regions implicated in articulation. Measured by voxel-based morphometry (VBM) analysis of high-resolution T1-weighted magnetic resonance imaging (MRI) scans.
Measured: From baseline to post-training assessment (at Week 12)
Change in Regional Homogeneity (ReHo) in Speech-Related Cortex
Changes in local brain activity synchronization across the whole brain, with particular emphasis on the speech-related cortex.
Measured: From baseline to post-training assessment (at Week 12)
Change in Amplitude of Low-Frequency Fluctuations (fALFF)
Changes in the fractional amplitude of low-frequency fluctuations in the blood-oxygen-level-dependent (BOLD) signal across the whole brain, assessed within regions of the speech and auditory processing networks. Derived from resting-state fMRI data.
Measured: From baseline to post-training assessment (at Week 12)
Change in Proportion of Compensatory Articulation Errors
Change in the proportion of compensatory (non-oral) articulation errors relative to the total number of consonants attempted, analyzed within both single-word and conversational speech samples. This metric is calculated through phonetic transcription of the speech samples to quantify the frequency of error patterns characteristic of non-oral articulation.
Measured: From baseline to post-training assessment (at Week 12)
Change in White Matter Volume (WMV) of Articulation-Related Regions
Alterations in white matter volume across the whole brain, particularly within tracts associated with speech motor pathways. Analyzed using voxel-based analysis of T1-weighted MRI to quantify white matter volume changes.
Measured: From baseline to post-training assessment (at Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start6 Jan 2019
- Primary completion27 May 2021
- Study completion21 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and/or PalateStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shufan Zhao
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Wenzhou Medical University, National Natural Science Foundation of China
- Responsible party
- Sponsor-investigator, Shufan Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07330687
- Sponsor's protocol ID
- 2017021923
- Acronym
- fMRI-Speech-CP
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A final decision regarding the sharing of individual participant data (IPD) has not been made at the time of this registration. This study involves sensitive neuroimaging and speech data. Data sharing considerations, including the feasibility of complete de-identification, compliance with local regulations and ethical approvals, and the establishment of appropriate data access protocols, require further review by the study investigators and sponsoring institution. A formal data sharing plan may be developed in the future and will be made available upon reasonable request or via a controlled-access repository if deemed feasible and appropriate.
Publications
Zhang W, Li C, Chen L, Xing X, Li X, Yang Z, Zhang H, Chen R. Increased activation of the hippocampus during a Chinese character subvocalization task in adults with cleft lip and palate palatoplasty and speech therapy. Neuroreport. 2017 Aug 16;28(12):739-744. doi: 10.1097/WNR.0000000000000832.
PubMed 28658048Wang Y, Deng C, Li H, Gao Y, Shi B, Huang X, Gong Q. Intranetwork and Internetwork Functional Connectivity Changes Related to Speech Disorders in Adults With Cleft Lip and Palate. Eur J Neurosci. 2025 Apr;61(7):e70077. doi: 10.1111/ejn.70077.
PubMed 40219708Zhang W, Guan Z, Cao L, Sun L, Zhang X, Chen R, Li C, Song W. Articulation-function-associated brain developmental changes in cleft lip and palate patients. Brain Res Bull. 2025 Sep;229:111458. doi: 10.1016/j.brainresbull.2025.111458. Epub 2025 Jul 11.
PubMed 40653058Zhang W, Zhao C, Sun L, Yang X, Yang L, Liang Y, Zhang X, Du X, Chen R, Li C. Articulation-Function-Associated Cortical Developmental Changes in Patients with Cleft Lip and Palate. Brain Sci. 2023 Mar 25;13(4):550. doi: 10.3390/brainsci13040550.
PubMed 37190514Wang S, Fang L, Miao G, Li Z, Rao B, Cheng H. Atypical cortical thickness and folding of language regions in Chinese nonsyndromic cleft lip and palate children after speech rehabilitation. Front Neurol. 2022 Sep 20;13:996459. doi: 10.3389/fneur.2022.996459. eCollection 2022.
PubMed 36203989Homoud NN, Ireland AJ, Sherriff M, AlSaffar Z, Davies AJV, Sandy JR. A Review and Meta-Analysis on Altered Brain Structure in Patients Born with Non-Syndromic Cleft Lip and/or Palate. Cleft Palate Craniofac J. 2026 May;63(5):1207-1215. doi: 10.1177/10556656251327526. Epub 2025 Mar 24.
PubMed 40129165
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brain Imaging Study of Abnormal Neural Network Reorganization Following Speech Training in Patients With Compensatory Articulation Secondary to Cleft Palate
- ClinicalTrials.gov ID
- NCT07330687
- Acronym / sponsor ID
- fMRI-Speech-CP / 2017021923
- Conditions
- Cleft Lip and/or Palate, Speech Disorder, Speech Therapy, Brain, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Shufan ZhaoUniversity, hospital or other
- Collaborators
- Guangzhou Women and Children's Medical Center, Wenzhou Medical University, National Natural Science Foundation of China
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 21 Aug 2021 (actual)
- First posted
- 9 Jan 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.
Cleft palate is one of the most common maxillofacial congenital malformations, which results in severe speech disorders. Compensatory articulation disorder, also known as non-oral articulation disorder (NOA), is considered as the major pathological change among these patients. However, the outcome of speech therapy, an important treatment method, for NOA is often unsatisfactory. This is attributed to the erroneous articulation patterns and entrenched habits in patients with NOA, which require considerable training intensity and time. According to preliminary results from the investigators' own study, as well as studies by others, structural and functional changes have been clearly identified in some brain regions of patients with NOA, suggesting that abnormal neural networks are involved in the progression of NOA. Thus, the investigators proposed the hypothesis that speech therapy effectively corrects articulation disorders through reconfiguration of pathological neural function and reorganization of the abnormal neural network involved in NOA. In this study, multimodal brain imaging techniques will be applied to investigate differences in brain functional connectivity and structural connectivity networks among groups with oral articulation (OA), varying degrees of NOA in postoperative cleft palate patients, and healthy controls. The relationship between improvement in speech intelligibility and alterations in brain networks before and after intervention will be compared. This study aims to reveal the neural network substrates associated with NOA and speech therapy. Overall, through this comprehensive study, the investigators aim not only to provide new insight into the underlying neural mechanism of NOA but also to accumulate evidence for improving the efficacy of speech therapy and discovering new therapeutic strategies in clinical practice.
Detailed description
Cleft palate often leads to compensatory articulation disorder (Non-oral Articulation, NOA), which is resistant to conventional speech therapy. This study is grounded in the hypothesis that the efficacy of speech training is mediated by the reorganization of pathological neural networks and structures associated with NOA.
This non-randomized, longitudinal study employs a parallel-group design involving three cohorts: patients with NOA receiving speech training, postoperative cleft palate patients with normal oral articulation (OA) as a clinical control, and healthy controls. The primary objective is to identify the distinctive neural signatures (in both functional connectivity and brain structure) linked to NOA and its remediation through training.
All participants undergo multimodal magnetic resonance imaging (including high-resolution T1-weighted and resting-state functional scans) and standardized speech assessments at baseline. Only the NOA group then receives a structured speech training intervention, followed by post-intervention reevaluation. By comparing changes within and between groups, this study aims to disentangle neural alterations specific to NOA from those related to cleft palate in general.
The integrative analysis of brain-wide changes with a focus on speech-related regions is expected to provide a systems-level understanding of the neural mechanisms underlying NOA and treatment-induced recovery. The findings may contribute to the development of more effective, neuroscience-informed therapeutic strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Oral Articulation(NOA) group | Experimental | Behavioral: Structured Speech Training for DecompensationParticipants receive the investigational behavioral intervention: Structured Speech Decompensation Therapy. This one-on-one therapy uses the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits, integrating multisensory cues. The intervention is administered by a certified speech therapist at a dosage of 1-hour sessions, with a frequency of 3 sessions per week, for a duration of 5 to 12 weeks. Parent participation in sessions and daily prescribed home practice are required components. |
| Oral Articulation (OA) Group | No intervention | –Participants do not receive the investigational speech training intervention. This arm serves as the clinical control group. |
| healthy control(HC) | No intervention | –Participants do not receive any study-related intervention. This arm serves as the healthy normative control group. |
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged between 4 and 16 years.
- For patient groups: Diagnosed with non-syndromic cleft palate and having undergone cleft palate repair surgery at least 1 year prior.
- For the NOA group: Diagnosed with compensatory articulation disorder (Non-oral Articulation, NOA) through standardized speech assessment.
- For the OA group: Confirmed to have no compensatory articulation disorder (Oral Articulation, OA) through standardized speech assessment.
- For the healthy control group: No history of any craniofacial malformations, speech disorders, or neurological diseases.
Key exclusion criteria (6 listed)
- Presence of other known syndromes or cognitive impairments (e.g., autism spectrum disorder, intellectual disability).
- History of other neurological diseases that may affect speech function (e.g., cerebral palsy, hearing loss).
- Presence of severe other orofacial anomalies, or an unrepaired palatal fistula.
- Contraindications for MRI examination (e.g., non-removable metal implants, severe claustrophobia).
- Having received systematic speech therapy within the past 6 months.
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 |
|---|---|---|
| Structured Speech Training for DecompensationThis structured, one-on-one speech decompensation therapy targets Non-oral Articulation Disorder (NOA) in postoperative cleft palate patients, using the glottal stop /kʔ/ as a key sound to guide correct articulation placement and correct compensatory habits. It follows a structured paradigm from error recognition to generalization, integrating multisensory cues. Delivered by a therapist 3 times/week for 1 hour over 5-12 weeks with parent participation, it includes daily home practice. Completion requires accurate sound production, with daily parent-supervised maintenance practice for one year thereafter. | Behavioural | Non-Oral Articulation(NOA) group |
Primary outcome
Change in Functional Connectivity of the Speech Related Network
Time frame: From baseline assessment to post-training assessment (approximately at Week 12)
Change in resting-state functional connectivity, focusing on connections between pre-defined speech-related regions (Broca's and Wernicke's areas) and additionally assessed through whole-brain network analysis, using resting-state fMRI data.
Change in Percent Correct Consonants (PCC)
Time frame: From baseline assessment to post-training assessment (approximately at Week 12)
Change in the percentage of consonants produced correctly, assessed within both single-word and conversational speech contexts. The measure is derived from standardized speech samples, which are evaluated by blinded, certified speech-language pathologists.
5 secondary outcomes
Change in Grey Matter Volume (GMV) of Articulation-Related Regions
Time frame: From baseline to post-training assessment (at Week 12)
Change in Regional Homogeneity (ReHo) in Speech-Related Cortex
Time frame: From baseline to post-training assessment (at Week 12)
Change in Amplitude of Low-Frequency Fluctuations (fALFF)
Time frame: From baseline to post-training assessment (at Week 12)
Change in Proportion of Compensatory Articulation Errors
Time frame: From baseline to post-training assessment (at Week 12)
Change in White Matter Volume (WMV) of Articulation-Related Regions
Time frame: From baseline to post-training assessment (at Week 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Results publication: PubMed 28658048Zhang W, Li C, Chen L, Xing X, Li X, Yang Z, Zhang H, Chen R. Increased activation of the hippocampus during a Chinese character subvocalization task in adults with cleft lip and palate palatoplasty and speech therapy. Neuroreport. 2017 Aug 16;28(12):739-744. doi: 10.1097/WNR.0000000000000832.
- Results publication: PubMed 40219708Wang Y, Deng C, Li H, Gao Y, Shi B, Huang X, Gong Q. Intranetwork and Internetwork Functional Connectivity Changes Related to Speech Disorders in Adults With Cleft Lip and Palate. Eur J Neurosci. 2025 Apr;61(7):e70077. doi: 10.1111/ejn.70077.
- Results publication: PubMed 40653058Zhang W, Guan Z, Cao L, Sun L, Zhang X, Chen R, Li C, Song W. Articulation-function-associated brain developmental changes in cleft lip and palate patients. Brain Res Bull. 2025 Sep;229:111458. doi: 10.1016/j.brainresbull.2025.111458. Epub 2025 Jul 11.
- Results publication: PubMed 37190514Zhang W, Zhao C, Sun L, Yang X, Yang L, Liang Y, Zhang X, Du X, Chen R, Li C. Articulation-Function-Associated Cortical Developmental Changes in Patients with Cleft Lip and Palate. Brain Sci. 2023 Mar 25;13(4):550. doi: 10.3390/brainsci13040550.
- Results publication: PubMed 36203989Wang S, Fang L, Miao G, Li Z, Rao B, Cheng H. Atypical cortical thickness and folding of language regions in Chinese nonsyndromic cleft lip and palate children after speech rehabilitation. Front Neurol. 2022 Sep 20;13:996459. doi: 10.3389/fneur.2022.996459. eCollection 2022.
- Results publication: PubMed 40129165Homoud NN, Ireland AJ, Sherriff M, AlSaffar Z, Davies AJV, Sandy JR. A Review and Meta-Analysis on Altered Brain Structure in Patients Born with Non-Syndromic Cleft Lip and/or Palate. Cleft Palate Craniofac J. 2026 May;63(5):1207-1215. doi: 10.1177/10556656251327526. Epub 2025 Mar 24.
- Individual participant dataSharing planned: No. A final decision regarding the sharing of individual participant data (IPD) has not been made at the time of this registration. This study involves sensitive neuroimaging and speech data. Data sharing considerations, including the feasibility of complete de-identification, compliance with local regulations and ethical approvals, and the establishment of appropriate data access protocols, require further review by the study investigators and sponsoring institution. A formal data sharing plan may be developed in the future and will be made available upon reasonable request or via a controlled-access repository if deemed feasible and appropriate.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Speech Training for Decompensation in people with Cleft Lip and/or Palate and Speech Disorder, run by Shufan Zhao 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 7 inclusion and 6 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: finished, as of the sponsor's last update on 3 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Connectivity of the Speech Related Network (time frame: From baseline assessment to post-training assessment (approximately at Week 12)). 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 NCT07330687, which also lists 6 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 3 Feb 2026.