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

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05467228

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Adductor Spasmodic Dysphonia Abductor Spastic Dysphonia Laryngeal Dystonia	Device: vibro-tactile stimulation (VTS)	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Low dose / continuous VTS Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech	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
Experimental: Low dose / speech activated VTS Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech	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
Experimental: High dose / continuous VTS High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech	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
Experimental: High dose / speech activated VTS High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech	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

Outcome Measures

Primary Outcome Measures

Change in perceived speech effort (PSE) [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 smoothed cepstral peak prominence (CPPS) [24 months]
CPPS provides a measure of the strength of the fundamental frequency within background aperiodicity (physical unit is dB)
Change in speech quality vector (SQV) (%) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.