Trial record 6 of 11 for:    Hemifacial Spasm

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01271634
First received: January 5, 2011
Last updated: July 22, 2011
Last verified: July 2011
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Latency from the root entry zone of facial nerve to the facial muscles [ Time Frame: up to 4 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Affiliated to 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
Study First Received: January 5, 2011
Last Updated: July 22, 2011
Health Authority: China: Ministry of Health

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

ClinicalTrials.gov processed this record on September 14, 2014