Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
试验速览
- 阶段
- 4 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
研究概览
简要总结
The purpose of this study is to evaluate the effects of pyridostigmine (Mestinon) on patient vocal outcomes after undergoing laryngeal botulinum neurotoxin (BoNT) injections, which is a standard treatment for spasmodic dysphonia. Pyridostigmine (Mestinon) has been used for treatment of BoNT overdose, and it is our hope that it will be beneficial in the management of post BoNT breathy phase.
详细描述
The study will enroll 10 subjects and will involve 1 clinic visit with two sessions over 2 hours.
Participants' voices will then be analyzed via sentence/passage reading, sustained vowel holding, maximum phonation time, as well as subjective ratings of effort. During the second clinic visit, participants will then be administered one 60mg tablet of pyridostigmine (Mestinon) orally, and asked to return to the clinic in 2 hours, when Mestinon has reached peak plasma concentration. Upon returning, participants will repeat the vocal analysis and results will be evaluated for any change in outcome.
Patients who are pregnant, lactating, or have kidney or heart disease should not participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females Aged 21-100
- •Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD)
排除标准
- •Subjects who are Pregnant or Lactating
- •Subjects with Compromised Renal or Cardiac Function
- •Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor
研究组 & 干预措施
Pyridostigmine (Mestinon)
Pyridostigmine (Mestinon) will be assigned to patients in this arm.
干预措施: Pyridostigmine Bromide 60 Milligrams (mg) (Drug)
结局指标
主要结局
Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon)
时间窗: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the glottal function index (GFI). A comparison between the pre-pyridostigmine GFI and post-pyridostigmine GFI will be performed to meet this outcome measure. Score is ranked from 0 to 5. The lower the GFI score indicates fewer problems/effort.
Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon)
时间窗: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another primary outcome measure being assessed is the adapted Borg scale. A comparison between the pre-pyridostigmine scale rating and the post-pyridostigmine scale rating will be performed to meet this outcome measure. The scale is ranked from 0 to 10. The higher the number indicates more effort in the tasks while a lower number indicates less effort.
Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon)
时间窗: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. One of the outcome measures used will be the Rainbow Passage reading. A comparison between pre-pyridostigmine reading and post-pyridostigmine reading will be performed to meet this outcome measure.
CAPE-V Pre- and Post-Pyridostigmine (Mestinon)
时间窗: 15 Minutes
This pilot study aims to evaluate the efficacy of pyridostigmine (Mestinon) to improve vocal outcomes following laryngeal chemo-denervation with botulinum neurotoxin injection which is a standard of care treatment of adductor spasmodic dysphonia. Another outcome measurement used will be the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V). A comparison between the pre-pyridostigmine evaluation of the CAPE-V and post-pyridostigmine evaluation of the CAPE-V will be performed to meet this outcome measure.
次要结局
未报告次要终点
研究者
Benjamin J Rubinstein
Assistant Professor
Eastern Virginia Medical School