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

Hemifacial Spasm Clinical Trial

Official title:

Observation of the Abnormal Potential From the Offending Vessel to the Facial Muscles of Hemifacial Spasm Patients

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01271634
• Other study ID #: xzheng-hfs-1
• Status: Enrolling by invitation
• Phase: N/A
• First received: January 5, 2011
• Last updated: July 22, 2011
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: July 2011
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemifacial Spasm

Locations

Country	Name	City	State
China	XinHua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Møller AR, Jannetta PJ. On the origin of synkinesis in hemifacial spasm: results of intracranial recordings. J Neurosurg. 1984 Sep;61(3):569-76. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal Potential From the Offending Vessel to the Facial Muscles		up to 4 months	No
Secondary	Latency from the root entry zone of facial nerve to the facial muscles		up to 4 months	No