A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients

Completed

• Conditions: Hemifacial Spasm

• Registration Number: NCT01728428
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects

Detailed Description

About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-09
• Status Verified: 2012-11
• Study Completion: 2012-11
• Study First Submitted: 2012-11-13
• Study First Submitted QC: 2012-11-13
• Last Update Submitted: 2012-11-13
• Study First Posted: 2012-11-19
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1003

Inclusion Criteria

1.Clinically diagnosed primary hemifacial spasm

1. Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
2. No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained

Exclusion Criteria

1. Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
2. Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
3. History of surgery of microvascular decompression of the facial nerve.
4. Participation in another clinical study currently.
5. Not able to understand and answer questionnaire.
6. Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of the treatment methods of HFS in outpatient subjects	November, 2012

Secondary Outcome Measures

Name	Time	Method
Distribution of onset age of hemifacial spasm patients	November, 2012
Analysis of aggrevated and relieved factors of HFS symptom	November, 2012
Analysis of concomitant symptoms of hemifacial spasm	November, 2012
Adverse events of botulinum toxin treatment in hemifacial spasm	November, 2012

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China