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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04295980
Other study ID # 81901175
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2022

Study information

Verified date March 2020
Source Beijing Tiantan Hospital
Contact Yuming Jiao, MD
Phone 8615010108242
Email shengxiongyuming@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 31, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

1. Signed the informed consent form;

2. The dominant hand is the right hand (evaluated by the Edinburgh hand scale);

3. BAVM located in the left inferior parietal lobe

4. No history of rupture and bleeding and neurosurgical treatment

Exclusion Criteria:

1. There are implants in the body (cardiac pacemaker, artificial femoral head, etc.);

2. The dominant hand is unclear;

3. Illiterate or other patients who can not cooperate well with cognitive function tests;

4. The history of bleeding in BAVM patients within one month;

5. History of neurosurgical treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Surgical removal of the BAVMs
Resection the BAVM nidus by microsurgery.

Locations

Country Name City State
China Beijing Tiantan Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Brain network of BAVMs in Geschwind's area compare the brain network of the Geschwind's area BAVMs patients and normal controls 2 years
Primary Brain network after injury of Geschwind's area compare the preoperative and postoperative brain network of Geschwind's area BAVMs. 2 years
Primary Brain network of the brain reorganization after surgery After surgery, we compare the brain network before and after the reorganization. 3 years
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