Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia

University of Minnesota1 site in 1 country40 target enrollmentSeptember 20, 2023

ConditionsSpasmodic Dysphonia Laryngeal Dystonia

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Spasmodic Dysphonia
Sponsor: University of Minnesota
Enrollment: 40
Locations: 1
Primary Endpoint: Perceived voice effort
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The general aim of the study is to provide evidence for usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (SD). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. Successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving voice symptoms in SD.

Registry

clinicaltrials.gov

Start Date

September 20, 2023

End Date

October 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University of Minnesota

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
•Diagnosis is made by a voice disorder specialist.

Exclusion Criteria

•Regular intake of benzodiazepines
•Cognitive impairment: score \< 27 on Mini-mental state examination
•Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, 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

Outcomes

Primary Outcomes

Perceived voice effort

Time Frame: 8 weeks

Participants will rate their perceived effort level of vocalization on an ordinal scale of 0 to 10 (0 being with no effort and 10 being with maximal effort). The recordings will provide subjective impression of treatment.