An interventional study of Botulinum Toxin Type A in Hemifacial Spasm, sponsored by Tongji University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-12.
Sponsored by Tongji University · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Patients of unilateral group were injected botulinum toxin type A to the affected hemiface.
Drug: 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.
Drug: Botulinum Toxin Type A
patients were injected to the normal side with dose of 1.25 units/per site
Also known as: Chinese botulinum toxin type A
Sunnybrook Facial Grading System
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
Time frame: up to 6 months
Symmetry Scale for Hemifacial Spasm
Symmetry Scale for Hemifacial Spasm consists of resting symmetry and symmetry of voluntary movement. Total score =Resting symmetry score + Symmetry of voluntary movement score
Time frame: up to 6 months
Facial Clinimetric Evaluation Scale
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.
Time frame: up to 6 months
The effective duration of botulinum toxin A
degree of amelioration in spasm and the effective duration of botulinum toxin A
Time frame: up to 6 months
Adverse events
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
Time frame: up to 6 months
Plan to share: Undecided
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Tongji University