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

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 2

Conditions: Abductor Spastic Dysphonia; Laryngeal Dystonia; Adductor Spasmodic Dysphonia

Treatments: Device: vibro-tactile stimulation (VTS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05467228

KIN-2022-30628

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Low dose / continuous VTS

Experimental group

Description:

Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Treatment:

Device: vibro-tactile stimulation (VTS)

Low dose / speech activated VTS

Experimental group

Description:

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

Treatment:

Device: vibro-tactile stimulation (VTS)

High dose / continuous VTS

Experimental group

Description:

High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Treatment:

Device: vibro-tactile stimulation (VTS)

High dose / speech activated VTS

Experimental group

Description:

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

Treatment:

Device: vibro-tactile stimulation (VTS)