NCT07537504

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

April 10, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

April 10, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

arteriovenous malformationslanguagefunctional magnetic resonance imagingreorganizationright cerebral hemisphere

Outcome Measures

Primary Outcomes (3)

  • Structural MRI (sMRI) Primary Metric

    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

    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

    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 Outcomes (1)

  • Multimodal Combined & Exploratory Metrics

    baseline and three months after surgery

Study Arms (2)

Healthy Control

Other: MRI

AVM patients

Other: MRI

Interventions

MRIOTHER

All participants underwent MRI scans

AVM patientsHealthy Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy Control and AVM patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Conditions

Arteriovenous MalformationsLanguage

Condition Hierarchy (Ancestors)

Vascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCommunicationBehavior

Study Officials

  • Xiaofeng Deng

    Brijing Tiantan Hospital

    STUDY CHAIR

Central Study Contacts

Xiaofeng Deng, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2026

First Posted

April 17, 2026

Study Start

April 20, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations