Language Function Reorganization in Patients With Arteriovenous Malformations

April 16, 2026 updated by: Beijing Tiantan Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • No. 119 South 4th Ring West Road, Fengtai District, Beijing 100070, China
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Control and AVM patients

Description

Inclusion Criteria:

  • AVM located within left-hemisphere language regions
  • right-handedness
  • native Mandarin Chinese speakers
  • age 18-60 years
  • high school education or above

Exclusion Criteria:

  • comorbid neurological or psychiatric disorders
  • AVM-related intracranial hemorrhage within the past month
  • prior AVM treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Control
Other: MRI
All participants underwent MRI scans
AVM patients
Other: MRI
All participants underwent MRI scans

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline and three months after surgery
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
baseline and three months after surgery
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
baseline and three months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Multimodal Combined & Exploratory Metrics
Time Frame: baseline and three months after surgery
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)
baseline and three months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Tiantan Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Xiaofeng Deng, Brijing Tiantan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KY2025-104-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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