Botulinum Toxin A in the Treatment of Hemifacial Spasm

Not Applicable

• Conditions: Hemifacial Spasm
• Interventions: Drug: Botulinum Toxin Type A

• Registration Number: NCT03306940
• Lead Sponsor: Tongji University

Brief Summary

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups. Group A received unilateral injection while group B received bilateral injection. Patients completed follow-up A researcher record facial videos and analyzed facial symmetry and completed 3 scales.

Detailed Description

Hemifacial spasm patients who received botulinum toxin A injection were divided into two groups.Patients of unilateral group were injected to the affected side and the dose of botulinum toxin A was 2.5-3.75 units/per site. Patients of bilateral group were injected to the affected side with dose of 2.5-3.75 units/per site and the normal side was injected with dose of 1.25 units/per site.

3 scales for measurement were used.

Study Timeline

• Status Verified: 2017-10
• Study Start: 2017-10-02
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-05
• Study First Posted: 2017-10-11
• Last Update Submitted: 2017-10-11
• Last Update Posted: 2017-10-12
• Primary Completion: 2018-07-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• clinical diagnosis of hemifacial spasm
• Scott grading III to IV
• hemifacial spasm duration of half or more years
• last botulinum toxin A application at least 3 months before the start of the study

Exclusion Criteria

• history of facial trauma, congenital facial asymmetry, facial nerve microsurgical decompression
• bilateral hemifacial spasm
• allergies to botulinum toxin A or to any component of the drug
• previous treatment with botulinum toxin A fewer than 3 months
• the use of drugs that could interfere with neuromuscular transmission or spasm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
unilateral injection group	Botulinum Toxin Type A	Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
bilateral injection group	Botulinum Toxin Type A	Patients of bilateral group were injected botulinum toxin type A to the affected hemiface and normal hemiface. The intervention of the bilateral group was that the normal side was injected.

Primary Outcome Measures

Name	Time	Method
Sunnybrook Facial Grading System	up to 6 months	Sunnybrook Facial Grading System consists of resting symmetry, symmetry of voluntary movement and synkinesis. Total score = Symmetry of voluntary movement score - Resting symmetry score - Synkinesis score

Secondary Outcome Measures

Name	Time	Method
Symmetry Scale for Hemifacial Spasm	up to 6 months	Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score
The effective duration of botulinum toxin A	up to 6 months	degree of amelioration in spasm and the effective duration of botulinum toxin A
Adverse events	up to 6 months	Adverse events, including stiff face, difficulty drinking and eating, difficulty controlling parotid and so on.The onset and duration of adverse events.Whether to take intervention to ameliorate adverse events and the efficacy of the intervention
Facial Clinimetric Evaluation Scale	up to 6 months	Facial Clinimetric Evaluation Scale consists of six parts:facial movement,facial comfort,oral function,eye comfort,lacrimal control and social function. Total score = facial movement + facial comfort + oral function + eye comfort + lacrimal control + social function.

Trial Locations

Locations (1)

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China