Dysphonia, Dysphonia, Spastic, Laryngeal Dystonia
Conditions
Keywords
pyridostigmine, dysphonia, spasmodic dysphonia, Mestinon, botulinum neurotoxin
Brief summary
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.
Detailed description
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.
Interventions
DRUGPyridostigmine Bromide 60 Milligrams (mg)
One tablet will be provided to patients during the second visit.
Sponsors
Eastern Virginia Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a pilot study so all 10 participants will be assigned to the pyridostigmine (Mestinon) treatment arm.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rainbow Passage Reading Pre- and Post-Pyridostigmine (Mestinon) | 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) | 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. |
| Glottal Function Index Pre- and Post-Pyridostigmine (Mestinon) | 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) | 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. |
Countries
United States
Contacts
Primary ContactAddy Tham, MS
Backup ContactLaura Stone, RN
Outcome results
None listed