N/A
N=42
Laryngeal Vibration for Spasmodic Dysphonia
Spasmodic Dysphonia
Bottom Line
View on ClinicalTrials.gov: NCT03746509 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Voice Assessment During First Visit — 0.045; 0.17; 0.13; -0.47 decibel
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Laryngeal Vibration (Treatment) (Device); Laryngeal Vibration (Comparator) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Voice Assessment During First Visit |
0.045; 0.17; 0.13; -0.47 | — |
| PRIMARY Final Voice Assessment |
0.96; 0.55; 0.64; 0.23 | — |
| SECONDARY Measuring of Cortical Activity Using Electroencephalography (EEG) (Baseline) |
— | — |
| SECONDARY Final Measuring of Cortical Activity Using Electroencephalography (EEG) to Measure Change From Baseline |
— | — |
Summary
The general aim of the research is to provide scientific evidence that vibro-tactile stimulation (VTS) represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of people with spasmodic dysphonia (SD). This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its long term efficacy.
Eligibility Criteria
Inclusion Criteria
- diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection
Exclusion Criteria
- abductor SD
- patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD
Data sourced from ClinicalTrials.gov (NCT03746509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.