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The Effect of Zinc Supplementation Prior to Botulinum Neurotoxin Type A Injection in the Treatment of Spasmodic Dysphonia
One initial study has shown that Botulinum Toxin (BT) in combination with zinc supplementation may increase the duration of effects BT treatment. This initial study was in the context of facial aesthetics. The purpose of the present study is to determine the effect, if any, of oral zinc supplementation prior to BT in the treatment of spasmodic dysphonia. If positive effects will be observed, this would help reduce the burden of disease for these patients.
Details
| Lead sponsor | University of Florida |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 36 |
| Start date | 2023-08-01 |
| Completion | 2025-12 |
Conditions
- Spasmodic Dysphonia
Interventions
- Zinc gluconate supplement
- Botulinum toxin type A
Primary outcomes
- Change of Voice-Related Quality of Life (V-RQOL) questionnaire scores during a laryngeal botox injection cycle. — The patient will submit survey on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with survey data obtained on post injection day 2, 7, 14, 42, 70, and 98
10 question, validated questionnaire to assess quality of voice of patients with spasmodic dysphonia. The overall VR-QOL score ranges from 10 to 15 (excellent), 16 to 20 (very good), 21 to 25 (good), 26-30 (fair) and scores more than 30 and up to 50 is poor. - Change in audiometric recording data of subject's speech during a laryngeal botox injection cycle. — The patient record their voice on post-injection day 2, 7, 14, 42, 70, and 98. At their next botox injection, a second cycle will immediately begin for an additional 3 months with audio data obtained on post injection day 2, 7, 14, 42, 70, and 98
At various points in the study, each subject will be recorded saying the same scripted passage. After all subjects have completed both cycles, all of the accrued audio recordings will be analyzed using a computer algorithm developed by one of our authors that assesses the quality of speech.
Countries
United States