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Observe Abnormal Potential From the Offending Vessel to the Facial Muscles of HFS Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271634
First Posted: January 7, 2011
Last Update Posted: July 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Jiao Tong University School of Medicine
  Purpose
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.

Condition
Hemifacial Spasm

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Observation of the Abnormal Potential From the Offending Vessel to the Facial Muscles of Hemifacial Spasm Patients

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Abnormal Potential From the Offending Vessel to the Facial Muscles [ Time Frame: up to 4 months ]

Secondary Outcome Measures:
  • Latency from the root entry zone of facial nerve to the facial muscles [ Time Frame: up to 4 months ]

Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll 20 cases of hemifacial spasm patients who want to undergo microvascular decompression.
Criteria

Inclusion Criteria:

  1. the age of 18-65 years old;
  2. with typical hemifacial spasm symptoms;
  3. with typical abnormal muscle response;
  4. preoperative magnetic resonance imaging revealed obvious paraneural artery;
  5. with informed consent.

Exclusion Criteria:

  1. pregnant or lactating women;
  2. accompanied by other serious diseases, including liver, kidney, cardiovascular diseases;
  3. accompanied by mental illness or severe neurosis;
  4. unable to express the subjective symptoms.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271634


Locations
China, Shanghai
XinHua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai, China, 200092
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xuesheng Zheng, M.D. Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

Publications:
Responsible Party: Xuesheng Zheng, XinHua Hospital, Affiliated to Shanghai JiaoTong University School of Medicine
ClinicalTrials.gov Identifier: NCT01271634     History of Changes
Other Study ID Numbers: xzheng-hfs-1
First Submitted: January 5, 2011
First Posted: January 7, 2011
Last Update Posted: July 25, 2011
Last Verified: July 2011

Keywords provided by Shanghai Jiao Tong University School of Medicine:
cross-transmission
offending vessel

Additional relevant MeSH terms:
Spasm
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs