NCT04295980

Brief Summary

At present, functional imaging studies have suggested that the Geschwind's territory (the inferior parietal lobe) is an important language area. It is the hub for semantics and phonetic language processing. However, the type and mechanism of aphasia after injury of Geschwind's territory and the subsequent recovery of language are still unclear. In our study based on brain injury model of brain arteriovenous malformation (BAVMs) resection, investigators found that the incidence of aphasia was higher after the injury of Geschwind's territory than after injury of the classical language area, and the type of aphasia was complicated, while the recovery rate of language disorder was high during follow-up. Investigators hypothesized that the type of aphasia may be associated with the type of brain connectivity damaged, and that reorganization of brain connections and brain network promote the recovery of language function. In this study, we aim to investigate the types of aphasia and their corresponding brain network changes after the resection of BAVMs located in the Geschwind's territory. Investigators will evaluate language function and collect multimodality images of the patients before resection of the lesions, as well as 7 days, 3 months and 6 months afterwards. In addition, the anatomical brain connectivity and brain network will also be analyzed. Our research will not only be a meaningful exploration for mechanisms of human language function damage and reorganization, but will also provide an important basis for the protection of brain function in neurosurgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

March 3, 2020

Last Update Submit

March 7, 2020

Conditions

AVM - Cerebral Arteriovenous MalformationLanguage

Outcome Measures

Primary Outcomes (3)

  • Brain network of BAVMs in Geschwind's area

    compare the brain network of the Geschwind's area BAVMs patients and normal controls

    2 years

  • Brain network after injury of Geschwind's area

    compare the preoperative and postoperative brain network of Geschwind's area BAVMs.

    2 years

  • Brain network of the brain reorganization after surgery

    After surgery, we compare the brain network before and after the reorganization.

    3 years

Study Arms (2)

Geschwind's area BAVMs

Procedure: Surgical removal of the BAVMs

Healthy controls

Interventions

Surgical removal of the BAVMsPROCEDURE

Resection the BAVM nidus by microsurgery.

Geschwind's area BAVMs

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

In this study, we will recruit 40 patients with BAVMs located in Geschwind's area, and recruit 40 healthy subjects as healthy control.

You may qualify if:

  • Signed the informed consent form;
  • The dominant hand is the right hand (evaluated by the Edinburgh hand scale);
  • BAVM located in the left inferior parietal lobe
  • No history of rupture and bleeding and neurosurgical treatment

You may not qualify if:

  • There are implants in the body (cardiac pacemaker, artificial femoral head, etc.);
  • The dominant hand is unclear;
  • Illiterate or other patients who can not cooperate well with cognitive function tests;
  • The history of bleeding in BAVM patients within one month;
  • History of neurosurgical treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Intracranial Arteriovenous MalformationsLanguage

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesIntracranial Arterial DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCommunicationBehavior

Central Study Contacts

Yuming Jiao, MD

CONTACT

8615010108242shengxiongyuming@163.com

Weilun Fu, MD

CONTACT

8618611165669doctorfwl@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

January 1, 2020

Primary Completion

July 1, 2022

Study Completion

December 31, 2022

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations

CN(1)