Dysphonia Clinical Trial
Official title:
Pilot Study of the Efficacy of Pyridostigmine for Reversal of Post Injection Dysphonia Following Botulinum Neurotoxin Laryngeal Chemo-Denervation in Spasmodic Dysphonia
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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | June 1, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: - Males and Females Aged 21-100 - Scheduled for Botulinum Neurotoxin (BoNT) Treatment for Spasmodic Dysphonia (SD) Exclusion Criteria: - Subjects who are Pregnant or Lactating - Subjects with Compromised Renal or Cardiac Function - Subjects with Spasmodic Dysphonia with Superimposed Vocal Tremor |
Country | Name | City | State |
---|---|---|---|
United States | Eastern Virginia Medical School Ear, Nose, and Throat Surgeons | Norfolk | Virginia |
Lead Sponsor | Collaborator |
---|---|
Eastern Virginia Medical School |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon) | 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. | 15 Minutes | |
Primary | CAPE-V Pre- and Post-Pyridostigmine (Mestinon) | 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. | 15 Minutes | |
Primary | Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon) | 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. | 15 Minutes | |
Primary | Adapted Borg Scale Pre- and Post-Pyridostigmine (Mestinon) | 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. | 15 Minutes |
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