Brain Arteriovenous MalformationsNCT07537504
Language Function Reorganization in Patients With Arteriovenous Malformations
An observational study of Brain Arteriovenous Malformations, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Brain arteriovenous malformation (AVM) is generally considered as a congenital lesion. Its unique clinical manifestation is that when the unruptured AVM involves and destroys the language function area of the left hemisphere, the patient has almost no language disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Arteriovenous Malformations
- What is being tested?
- MRI
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 31 Dec 2027
- Phase
- Observational
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy Control and AVM patients
Who may be able to join
- AVM located within left-hemisphere language regions
- right-handedness
- native Mandarin Chinese speakers
- age 18-60 years
- high school education or above
Who cannot join
- comorbid neurological or psychiatric disorders
- AVM-related intracranial hemorrhage within the past month
- prior AVM treatment
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
No. 119 South 4th Ring West Road, Fengtai District, Beijing 100070, China
Beijing
Xiaofeng Deng, MD, +8613426341444, windmessenger@126.com
Zekun Han, MM, +8613523485634, ZKHan0810@163.com
About this study
Official title: Study on the Language Function Reorganization in Right CerebralHemisphere of Patients With Brain Arteriovenous Malformations Using Multimodal MRI
Brain arteriovenous malformation (AVM) is generally considered as a congenital lesion. Its unique clinical manifestation is that when the unruptured AVM involves and destroys the language function area of the left hemisphere, the patient has almost no language disorder. This phenomenon is distinct from those of acquired diseases such as cerebral infarction and gliomas. There is a hypothesis that it might be associated with that the occurrence of AVM is earlier than period of language learning. Therefore, patients with AVMs involving language areas can be regarded as population whose language areas are congenital "knocked out" but the language functions remain normal, which provide a special model and new insights for language reorganization research. Previous studies have found that the right hemisphere plays an important role in the remodeling of language function in patients with AVMs, but the specific mechanism remains unclear. The purpose of this study is to further elaborate the role of the right cerebral hemisphere in the reorganized language network and the interhemispheric interaction mechanisms in patients with AVMs involving the language areas, using multimodal magnetic resonanceimaging and from multiple dimensions such as functional remodeling, white matter pathway remodeling, structural remodeling, etc., so as to further understand the remodeling mechanism of the Chinese language network after damage of language areas, and also to provide a theoretical basis for the protection of language function in brain network surgery.
- Conditions
- Brain Arteriovenous Malformations
- Being tested
- MRI
- Keywords
- arteriovenous malformations, language, functional magnetic resonance imaging, reorganization, right cerebral hemisphere
- Medical subject headings
- Arteriovenous Malformations, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
All participants underwent MRI scans
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control | Not described Receives: Other: MRI | |
| AVM patients | Not described Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structural MRI (sMRI) Primary Metric
Cortical thickness of bilateral language-related brain regions (measured via FreeSurfer); intergroup differences between AVM patients and healthy controls
Measured: baseline and three months after surgery
Functional MRI Secondary Metrics
Resting-state regional brain activity: Amplitude of Low Frequency Fluctuation (ALFF) and Regional Homogeneity (ReHo) Dynamic effective connectivity (DCM): Excitatory/inhibitory effective connectivity between lesioned left hemisphere and remodeled right hemisphere regions
Measured: baseline and three months after surgery
Diffusion MRI (dMRI) Primary Metrics
White matter microstructural integrity: Fractional Anisotropy (FA, DTI) and Neurite Density Index (NDI, NODDI) of language-related white matter tracts Corpus callosum diffusion metrics (FA, NDI) reflecting interhemispheric communication
Measured: baseline and three months after surgery
Secondary outcomes (1)
Multimodal Combined & Exploratory Metrics
Function-structure coupling: Correlation analysis between fMRI LI, cortical thickness, and white matter FA/NDI Track-weighted dynamic functional connectivity (TW-dFC): White matter tract-mediated dynamic functional interactions Graph theory brain network analysis: Global efficiency, local efficiency, nodal degree, and modularity of the language network Subgroup comparative metrics: Neuroimaging differences between right-hemisphere remodelers and non-remodelers Correlation between imaging metrics and basic demographic/clinical variables (age, lesion location)
Measured: baseline and three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Arteriovenous MalformationsStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaofeng Deng, Study chair, Brijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537504
- Sponsor's protocol ID
- KY2025-104-01
- Status last verified
- Mar 2026
- First submitted
- 10 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Language Function Reorganization in Right CerebralHemisphere of Patients With Brain Arteriovenous Malformations Using Multimodal MRI
- ClinicalTrials.gov ID
- NCT07537504
- Acronym / sponsor ID
- KY2025-104-01
- Conditions
- Brain Arteriovenous Malformations
- Keywords
- arteriovenous malformations, language, functional magnetic resonance imaging, reorganization, right cerebral hemisphere
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 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.
Brain arteriovenous malformation (AVM) is generally considered as a congenital lesion. Its unique clinical manifestation is that when the unruptured AVM involves and destroys the language function area of the left hemisphere, the patient has almost no language disorder. This phenomenon is distinct from those of acquired diseases such as cerebral infarction and gliomas. There is a hypothesis that it might be associated with that the occurrence of AVM is earlier than period of language learning. Therefore, patients with AVMs involving language areas can be regarded as population whose language areas are congenital "knocked out" but the language functions remain normal, which provide a special model and new insights for language reorganization research. Previous studies have found that the right hemisphere plays an important role in the remodeling of language function in patients with AVMs, but the specific mechanism remains unclear. The purpose of this study is to further elaborate the role of the right cerebral hemisphere in the reorganized language network and the interhemispheric interaction mechanisms in patients with AVMs involving the language areas, using multimodal magnetic resonanceimaging and from multiple dimensions such as functional remodeling, white matter pathway remodeling, structural remodeling, etc., so as to further understand the remodeling mechanism of the Chinese language network after damage of language areas, and also to provide a theoretical basis for the protection of language function in brain network surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: MRI |
| AVM patients | – | Other: MRI |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy Control and AVM patients
Key inclusion criteria (5 listed)
- AVM located within left-hemisphere language regions
- right-handedness
- native Mandarin Chinese speakers
- age 18-60 years
- high school education or above
Key exclusion criteria (3 listed)
- comorbid neurological or psychiatric disorders
- AVM-related intracranial hemorrhage within the past month
- prior AVM treatment
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 |
|---|---|---|
| MRIAll participants underwent MRI scans | Other | AVM patients, Healthy Control |
Primary outcome
Structural MRI (sMRI) Primary Metric
Time frame: baseline and three months after surgery
Cortical thickness of bilateral language-related brain regions (measured via FreeSurfer); intergroup differences between AVM patients and healthy controls
Functional MRI Secondary Metrics
Time frame: baseline and three months after surgery
Resting-state regional brain activity: Amplitude of Low Frequency Fluctuation (ALFF) and Regional Homogeneity (ReHo) Dynamic effective connectivity (DCM): Excitatory/inhibitory effective connectivity between lesioned left hemisphere and remodeled right hemisphere regions
Diffusion MRI (dMRI) Primary Metrics
Time frame: baseline and three months after surgery
White matter microstructural integrity: Fractional Anisotropy (FA, DTI) and Neurite Density Index (NDI, NODDI) of language-related white matter tracts Corpus callosum diffusion metrics (FA, NDI) reflecting interhemispheric communication
1 secondary outcome
Multimodal Combined & Exploratory Metrics
Time frame: baseline and three months after surgery
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 17 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Xiaofeng Deng study chair
Brijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Arteriovenous Malformations, run by Beijing Tiantan Hospital 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Apr 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 Xiaofeng Deng, MD (+8613426341444, windmessenger@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural MRI (sMRI) Primary Metric (time frame: baseline and three months after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2026; AzTrials last refreshed its copy on 27 Oct 2026.