Blepharospasm, Hemifacial Spasm
Conditions
Keywords
Blepharospasm, Hemifacial spasm, Botox, Zinc
Brief summary
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
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.
Interventions
DRUGZinc Supplement
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.
DRUGSugar pill
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.
Sponsors
St. Joseph's Healthcare Hamilton
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Jankovic Rating Scale | 3 months post Botox injection | a well established scale used in the literature to grade the symptoms of patients with facial spasms disorders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Duration Cycle | 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. | The number of days between the date of Botox injection to the date in which the symptoms have returned back to baseline. |
| Blepharospasm Disability Index (BDI) | 3 months post Botox injection | 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. |
Countries
Canada
Contacts
Primary ContactGamal Seif, MD
Backup ContactJohn Harvey, MD
Outcome results
None listed