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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01728428

Enrollment

1003

Registered

2012-11-19

Start date

2012-02-29

Completion date

2012-11-30

Last updated

2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemifacial Spasm

Keywords

hemifacial spasm, observational study, clinical manifestation, treatment, Chinese

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.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The percentage of the treatment methods of HFS in outpatient subjects	November, 2012

Secondary

Measure	Time frame
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

Countries

China

Outcome results