AVM - Cerebral Arteriovenous MalformationNCT04295980
Mechanism of Aphasia and Recovery of Language After the Injury of Geschwind's Territory: a Study Based on the Brain Network Analysis
An observational study of AVM - Cerebral Arteriovenous Malformation and Language, run by Beijing Tiantan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- AVM - Cerebral Arteriovenous Malformation, Language
- What is being tested?
- Surgical removal of the BAVMs
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070
Yuming Jiao, MD, 8615010108242, shengxiongyuming@163.com
Weilun Fu, MD, 8618611165669, doctorfwl@163.com
About this study
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.
- Being tested
- Surgical removal of the BAVMs
- Medical subject headings
- Intracranial Arteriovenous Malformations, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removal of the BAVMsProcedure or surgery
Resection the BAVM nidus by microsurgery.
| Study group | Role | What they receive |
|---|---|---|
| Geschwind's area BAVMs | Not described Receives: Procedure: Surgical removal of the BAVMs | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain network of BAVMs in Geschwind's area
compare the brain network of the Geschwind's area BAVMs patients and normal controls
Measured: 2 years
Brain network after injury of Geschwind's area
compare the preoperative and postoperative brain network of Geschwind's area BAVMs.
Measured: 2 years
Brain network of the brain reorganization after surgery
After surgery, we compare the brain network before and after the reorganization.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AVM - Cerebral Arteriovenous MalformationStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiao Yuming, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295980
- Sponsor's protocol ID
- 81901175
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 10 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Aphasia and Recovery of Language After the Injury of Geschwind's Territory: a Study Based on the Brain Network Analysis
- ClinicalTrials.gov ID
- NCT04295980
- Acronym / sponsor ID
- 81901175
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geschwind's area BAVMs | – | Procedure: Surgical removal of the BAVMs |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical removal of the BAVMsResection the BAVM nidus by microsurgery. | Procedure or surgery | Geschwind's area BAVMs |
Primary outcome
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
Brain network after injury of Geschwind's area
Time frame: 2 years
compare the preoperative and postoperative brain network of Geschwind's area BAVMs.
Brain network of the brain reorganization after surgery
Time frame: 3 years
After surgery, we compare the brain network before and after the reorganization.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AVM - Cerebral Arteriovenous Malformation and Language, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuming Jiao, MD (8615010108242, shengxiongyuming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain network of BAVMs in Geschwind's area (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2020.