BTATHS: Botulinum Toxin A in the Treatment of Hemifacial Spasm

Sponsor

Tongji University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03306940

Collaborator

(none)

Enrollment

Location

Arms

10.9

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemifacial Spasm	Drug: Botulinum Toxin Type A	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Does Bilateral Botulinum Toxin A in Patients With Hemifacial Spasm Improve Facial Symmetry Unilateral and Bilateral Injection of Botulinum Toxin A in Patients With Hemifacial Spasm? A Prospective, Randomized, Controlled Study

Actual Study Start Date :

Oct 2, 2017

Anticipated Primary Completion Date :

Jul 31, 2018

Anticipated Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: unilateral injection group Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.	Drug: Botulinum Toxin Type A patients were injected to the normal side with dose of 1.25 units/per site Other Names: Chinese botulinum toxin type A
Experimental: bilateral injection group 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.	Drug: Botulinum Toxin Type A patients were injected to the normal side with dose of 1.25 units/per site Other Names: Chinese botulinum toxin type A

Arm

Intervention/Treatment

Placebo Comparator: unilateral injection group

Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.

Drug: Botulinum Toxin Type A

patients were injected to the normal side with dose of 1.25 units/per site

Other Names:

Chinese botulinum toxin type A

Experimental: bilateral injection group

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.

Drug: Botulinum Toxin Type A

patients were injected to the normal side with dose of 1.25 units/per site

Other Names:

Chinese botulinum toxin type A

Outcome Measures

Primary Outcome Measures

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

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
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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