- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04295980
Mechanism of Aphasia and Recovery of Language After the Injury of Geschwind's Territory: a Study Based on the Brain Network Analysis
March 7, 2020 updated by: Jiao Yuming, Beijing Tiantan Hospital
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100070
- Recruiting
- Beijing Tiantan Hospital, Capital Medical University
-
Contact:
- Yuming Jiao, MD
- Phone Number: 8615010108242
- Email: shengxiongyuming@163.com
-
Contact:
- Weilun Fu, MD
- Phone Number: 8618611165669
- Email: doctorfwl@163.com
-
-
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
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability 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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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 |
Intervention / Treatment |
|---|---|
|
Healthy controls
|
|
|
Geschwind's area BAVMs
|
Resection the BAVM nidus by microsurgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain network of BAVMs in Geschwind's area
Time Frame: 2 years
|
compare the brain network of the Geschwind's area BAVMs patients and normal controls
|
2 years
|
|
Brain network after injury of Geschwind's area
Time Frame: 2 years
|
compare the preoperative and postoperative brain network of Geschwind's area BAVMs.
|
2 years
|
|
Brain network of the brain reorganization after surgery
Time Frame: 3 years
|
After surgery, we compare the brain network before and after the reorganization.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
January 1, 2020
Primary Completion (ANTICIPATED)
July 1, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 3, 2020
First Posted (ACTUAL)
March 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 10, 2020
Last Update Submitted That Met QC Criteria
March 7, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Cardiovascular Abnormalities
- Nervous System Malformations
- Vascular Malformations
- Language Disorders
- Communication Disorders
- Intracranial Arterial Diseases
- Speech Disorders
- Central Nervous System Vascular Malformations
- Arteriovenous Malformations
- Aphasia
- Intracranial Arteriovenous Malformations
Other Study ID Numbers
- 81901175
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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