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

Phase 2

Withdrawn

• Conditions: Abductor Spastic Dysphonia; Laryngeal Dystonia; Adductor Spasmodic Dysphonia
• Interventions: Device: vibro-tactile stimulation (VTS)

• Registration Number: NCT05467228
• Lead Sponsor: University of Minnesota

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16
• Study Start: 2026-08
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low dose / continuous VTS	vibro-tactile stimulation (VTS)	Low dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
High dose / speech activated VTS	vibro-tactile stimulation (VTS)	High dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
Low dose / speech activated VTS	vibro-tactile stimulation (VTS)	Low dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
High dose / continuous VTS	vibro-tactile stimulation (VTS)	High dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech

Primary Outcome Measures

Name	Time	Method
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 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
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)

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States