Testing the Effect of Zinc Supplementation to Improve the Treatment Effect of Botulinum Toxin for Oculofacial Spasm

Study Overview
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Brief Summary
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The purpose of this study is to determine whether zinc supplements are effective in enhancing the treatment of oculofacial spasm disorders with botulinum toxin.

Detailed Description
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Botulinum Toxin (Botox) has been used for many years in the treatment of oculofacial dystonias such as blepharospasm and hemifacial spasm. It has also gained widespread use for cosmetic purposes. The efficacy and duration of its effect is not constant amongst all patients. Some patient respond very well, while others have no clinical benefit or the clinical benefit does not last as long as expected. Zinc is known to be an important co-factor in the molecular effects of Botox. The investigators hypothesize that one of the many factors that may contribute to the variability in the response to Botox may be the level of Zinc available within the neuromuscular junction of those patients. The investigators plan to to test whether or not giving patients supplemental Zinc with their Botox injections would help improve the magnitude and duration of the intended clinical effect.

Official Title
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The Effect of Zinc Supplementation on the Efficacy and Duration of Botulinum Toxin for the Treatment of Oculofacial Spasm Disorders

Conditions
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Blepharospasm, Hemifacial Spasm

Intervention / Treatment
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* Drug: Zinc Supplement
* Drug: Sugar pill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: greater than the age 18 years old patient with hemifacial spasm patient with benign essential blepharospasm. Exclusion Criteria: patients who have received Botox within 3 months time, patients prone to malabsorption (i.e. those with Celiac disease, inflammatory bowel disease, liver disease, laxative use) patients who cannot tolerate zinc supplementation due to kidney disease, gastrointestinal disease, or any other medical condition.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Sugar pill<br>* The control group will be requested to take placebo pills, once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.<br>|
| Experimental: Zinc Group<br> | Drug: Zinc Supplement<br>* The interventional group will be requested to take zinc supplements (50mg), once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jankovic Rating Scale | a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders. | 3 months post Botox injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Duration Cycle | The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline. | The time frame will vary with each patient. The time frame is in fact the outcome measure being measured. On average the Botox treatment cycles last 3 months, however this average may be affected by zinc supplements. | 
| Blepharospasm Disability Index (BDI) | BDI is a scale commonly used in the Blepharospasm literature to measure the magnitude of the burden of symptoms in patients with Blepharospasm. It has also been used to measure treatment effect by a reduction in patient's BDI. | 3 months post Botox injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Blepharospasm, Hemifacial spasm, Botox, Zinc