Cervical Dystonia
Conditions
Keywords
cervical dystonia, botulinum toxin, Botox, zinc citrate, zinc
Brief summary
The goal of this clinical trial is to evaluate if supplemental zinc can prolong the duration of benefit of botulinum toxin injections in cervical dystonia patients receiving care at the University of Florida. The main aims are: 1. To evaluate the efficacy of zinc citrate supplementation in prolonging the duration of symptom relief provided by botulinum toxin type A (Botox) injections in cervical dystonia patients. 2. To assess the safety and tolerability of zinc supplementation in this patient population. 3. To analyze the potential influence of zinc supplementation on the quality of life and functional outcomes in cervical dystonia patients receiving Botox. Researchers will compare zinc citrate to a placebo (a look-alike substance that contains no active drug) to see if zinc works to extend the effects of Botox. Participants will: Take zinc citrate or a placebo every day for 3 months, then cross over to the alternative treatment for another 3 months. Visit the clinic every 3 months for Botox injections, check ups and surveys.
Detailed description
Study Design: * Randomized, single-blind, crossover placebo-controlled trial. * Participants: Approximately 20 patients diagnosed with cervical dystonia and currently receiving botulinum toxin (BoNT) type A (Botox) injections at the University of Florida (UF) Movement Disorders Clinic with good response to treatment as determined by treating neurologist will be enrolled into this study. The investigators plan to screen 25 patients to allow for screen failures and withdrawals. * Intervention: Participants will be randomized to receive either zinc citrate 30 mg supplementation or placebo starting immediately after their scheduled BoNT injection for 3 months. At a follow up BoNT injection, they will receive the alternative treatment for another 3 months. The total observation period is 6 months. Standard time between BoNT injections is 3 months. The UF Movement Disorders Clinic follows approximately 1,500 cervical dystonia patients a year. The investigators do not anticipate any recruitment challenges. Participants will be recruited during neurology clinic appointments and screening clinic appointments. * Patients will receive the same pattern of BoNT injections (muscle selection and dose) during the duration of the study. * Blood serum levels of zinc and vitamin B12 and complete blood counts (CBCs) will be measured at baseline and at the end of the study. Participants will be sent to UF Health Medical lab for blood draws and sample collection. * Written informed consent will be obtained from each participant before any study-specific procedures or assessments are performed. Inclusion Criteria: * Adults aged 18-65 years. * Diagnosed with cervical dystonia. * Receiving regular BoNT type A (Botox) injections for at least one year. Exclusion Criteria: * Known allergy or intolerance to zinc. * Significant comorbidities or concurrent medications that could interfere with study outcomes. * Pregnant or breastfeeding women. * Already taking a zinc supplement which would exceed tolerable upper intake level in adults (40 mg elemental zinc per day) with addition of zinc study supplement
Interventions
DRUGZinc citrate
Oral zinc citrate 30 mg daily
DRUGPlacebo
Placebo
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 18-65 years. * Diagnosed with cervical dystonia. * Receiving regular BoNT type A (Botox) injections for at least one year.
Exclusion criteria
* Known allergy or intolerance to zinc. * Significant comorbidities or concurrent medications that could interfere with study outcomes. * Pregnant or breastfeeding women. * Already taking a zinc supplement which would exceed tolerable upper intake level in adults (40 mg elemental zinc per day) with addition of zinc study supplement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Botox efficacy | 3 and 6 month post intervention | Time to return to baseline symptom severity using the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Severity Subscale. The TWSTRS Severity Subscale is scored from 0 to 35, with higher numbers indicating a more severe condition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Severity at 3 months | 3 months post intervention | Change in pain severity at 3 months as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Pain Subscale. The TWSTRS Pain Subscale is scored from 0 to 20, with higher numbers indicating a more painful condition. |
| Change in Quality of Life at 3 months | 3 months post intervention | Change in quality of life at 3 months as measured by the Craniocervical dystonia questionnaire (CDQ-24). The CDQ-24 contains 24 items pertaining to quality of life in patients with cervical dystonia, scored from 0 ("never") to 4 ("very severely"). |
| Change in Functional Disability at 3 months | 3 months post intervention | Change in functional disability at 3 months as measured by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Disability Subscale. The TWSTRS Disability Subscale is scored from 0 to 30 with higher numbers indicating a more disabling condition. |
| Patient Global Impression of Change | 3 months post intervention | Patient Global Impression of Change (PGIC) at 3 months. The PGIC measures the patient's perception of the change in their condition after treatment, scored from 1 ("Very much improved") to 7 ("Very much worse"). |
| Clinician Global Impression of Change | 3 months post intervention | Clinician Global Impression of Change (CGIC) at 3 months. The CGIC measures the researcher's perception of the change in the patient's condition after treatment, scored from 1 ("Very much improved") to 7 ("Very much worse"). |
Countries
United States
Contacts
CONTACTJulie Segura, BA
PRINCIPAL_INVESTIGATORLauren Fanty, MD
University of Florida
Outcome results
None listed