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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Zinc Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zinc Supplement | Drug | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gamal Seif, MD | Contact | 9054073882 | gamal.seif@medportal.ca | |
| John Harvey, MD | Contact | 905-573-4848 | jtharvey@mcmaster.ca |
| Name | Affiliation | Role |
|---|---|---|
| John Harvey, MD | St Joseph's Hospital Hamilton | Principal Investigator |
| Yasser Khan, MD | McMaster University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Hospital Hamilton | Hamilton | Ontario | L8N4A6 | Canada |
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| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| D019569 | Hemifacial Spasm |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
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| Sugar pill | Drug | 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. |
|
| 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 |
| Carrot Eye Centre | Mississauga | Ontario | L5J 2Y2 | Canada |
|
| D013035 |
| Spasm |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |