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

NCT ID: NCT05467228

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-08-31
• Study Completion Date: 2026-08-01

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).

Conditions

Adductor Spasmodic Dysphonia; Abductor Spastic Dysphonia; Laryngeal Dystonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

vibro-tactile stimulation (VTS)

Intervention Type: DEVICE

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

Low dose / speech activated VTS

Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech

Group Type: EXPERIMENTAL

vibro-tactile stimulation (VTS)

Intervention Type: DEVICE

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

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

Group Type: EXPERIMENTAL

vibro-tactile stimulation (VTS)

Intervention Type: DEVICE

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

High dose / speech activated VTS

High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech

Group Type: EXPERIMENTAL

vibro-tactile stimulation (VTS)

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

KIN-2022-30628

Identifier Type: -

Identifier Source: org_study_id