- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01271634
Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients
July 22, 2011 updated by: Shanghai Jiao Tong University School of Medicine
Observation of the Abnormal Potential From the Offending Vessel to the Facial Muscles of Hemifacial Spasm Patients
The pathophysiologic basis of hemifacial spasm is cross-transmission between different branches of the facial nerve.
The hypothesis is that the cross-transmission is mediated by the sympathetic nerve fibers on the surface of the offending artery.
The abnormal potential from the offending vessel to the facial muscles will be detected on hemifacial spasm patients, so as to determine if the sympathetic nerve fibers take part in the circuit of cross-transmission.
Study Overview
Status
Unknown
Conditions
Detailed Description
It's hypothesized that at the location where the facial nerve is compressed by an artery, ephaptic cross-transmission takes place between the nude facial nerve fibers and the sympathetic nerve fibers on the arterial surface.
Thus action potentials could spread indirectly from one facial nerve fiber to several other facial nerve fibers (via the "bridge" of sympathetic fibers), or directly from the sympathetic fibers to facial nerve fibers.
The investigators assume this is the electrophysiological basis of hemifacial spasm and its characteristic sign abnormal muscle response (AMR).
If an abnormal potential from the offending artery to the facial muscles similar to AMR can be recorded, the hypothesis will be verified.
Study Type
Observational
Enrollment (Anticipated)
20
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
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Shanghai
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Shanghai, Shanghai, China, 200092
- Xinhua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
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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 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
This study will enroll 20 cases of hemifacial spasm patients who want to undergo microvascular decompression.
Description
Inclusion Criteria:
- the age of 18-65 years old;
- with typical hemifacial spasm symptoms;
- with typical abnormal muscle response;
- preoperative magnetic resonance imaging revealed obvious paraneural artery;
- with informed consent.
Exclusion Criteria:
- pregnant or lactating women;
- accompanied by other serious diseases, including liver, kidney, cardiovascular diseases;
- accompanied by mental illness or severe neurosis;
- unable to express the subjective symptoms.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Abnormal Potential From the Offending Vessel to the Facial Muscles
Time Frame: up to 4 months
|
up to 4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Latency from the root entry zone of facial nerve to the facial muscles
Time Frame: up to 4 months
|
up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xuesheng Zheng, M.D., Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
January 1, 2011
Primary Completion (ANTICIPATED)
December 1, 2011
Study Completion (ANTICIPATED)
December 1, 2011
Study Registration Dates
First Submitted
January 5, 2011
First Submitted That Met QC Criteria
January 6, 2011
First Posted (ESTIMATE)
January 7, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
July 25, 2011
Last Update Submitted That Met QC Criteria
July 22, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- xzheng-hfs-1
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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