Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia

Laryngeal Dystonia Clinical Trial

Official title:

Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05467228
• Other study ID #: KIN-2022-30628
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2025
• Est. completion date: August 1, 2026

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: Jürgen Konczak, PhD
• Phone: 612-624-4370
• Email: jkonczak[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adductor Spasmodic Dysphonia
• Dysphonia
• Dystonia
• Dystonic Disorders
• Hoarseness
• Laryngeal Dystonia
• Muscle Spasticity

Intervention

Device:
• vibro-tactile stimulation (VTS)
To apply vibro-tactile stimulation, participants will use a wearable device. It contains two vibratory motors (Precision MicrodrivesTM, Model 307 - 100) that are low-voltage (~1V), non-invasive and will be located approximately above the lateral portions of the thyroid cartilage. For this protocol, they vibrate at frequencies between 40 - 100 Hz (i.e., 100 times per second

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in perceived speech effort (PSE)	Speaker will assess effort themselves and assign an score (range: 0-10 with a score of '10' indicating most severe effort)	24 months
Primary	Change in smoothed cepstral peak prominence (CPPS)	CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)	24 months
Primary	Change in speech quality vector (SQV) (%)	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	24 months