NCT01271634

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 25, 2011

Status Verified

July 1, 2011

Enrollment Period

11 months

First QC Date

January 5, 2011

Last Update Submit

July 22, 2011

Conditions

Keywords

cross-transmissionoffending vessel

Outcome Measures

Primary Outcomes (1)

  • Abnormal Potential From the Offending Vessel to the Facial Muscles

    up to 4 months

Secondary Outcomes (1)

  • Latency from the root entry zone of facial nerve to the facial muscles

    up to 4 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll 20 cases of hemifacial spasm patients who want to undergo microvascular decompression.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

XinHua Hospital, Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (1)

  • Moller AR, Jannetta PJ. On the origin of synkinesis in hemifacial spasm: results of intracranial recordings. J Neurosurg. 1984 Sep;61(3):569-76. doi: 10.3171/jns.1984.61.3.0569.

    PMID: 6086858BACKGROUND

MeSH Terms

Conditions

Hemifacial Spasm

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Xuesheng Zheng, M.D.

    Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 7, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 25, 2011

Record last verified: 2011-07

Locations