Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Adductor Spasmodic Dysphonia
- Sponsor
- University of Minnesota
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Change in perceived speech effort (PSE)
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
Brief 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 patients with laryngeal dystonia (LD) - also called spasmodic dysphonia (SD).
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older
- •Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
Exclusion Criteria
- •Regular intake of benzodiazepines
- •Cognitive impairment: score \< 27 on the Mini-mental State Examination (MMSE).
- •Identify with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia other than LD, Essential Tremor, Huntington's Disease, Multiple System Atrophy, Muscle Tension Dysphonia, Parkinsonism, Progressive Supranuclear Palsy, Spasticity, Intracranial Neoplasm (brain tumor), Spinal Neoplasm, Cerebrovascular Accident (Stroke), Mild Traumatic Brain Injury, Intracranial Hemorrhage, Multiple Sclerosis.
- •Non-English speaker. We will not enroll people who cannot speak English, because the voice assessment procedures (Test sentences, CAPE_V clinical rating) have only been validated for English speakers at this point.
- •Pregnant people. We will not enroll pregnant people as the device used in this study is investigational.
Outcomes
Primary Outcomes
Change in perceived speech effort (PSE)
Time Frame: 24 months
Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)
Change in speech quality vector (SQV) (%)
Time Frame: 24 months
A derived measure designed to understand if a participant's voice symptom improvement occurs across objective (CPPS) and subjective measures of speech (PSE). It is based on the relative change between two time points
Change in smoothed cepstral peak prominence (CPPS)
Time Frame: 24 months
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)