Study Stopped
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Laryngeal Vibro-tactile Stimulation as a Non-invasive Symptomatic Treatment for Spasmodic Dysphonia
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
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Started Aug 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2022
CompletedFirst Posted
Study publicly available on registry
July 20, 2022
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
Study Completion
Last participant's last visit for all outcomes
August 1, 2026
May 16, 2025
May 1, 2025
Same day
July 12, 2022
May 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
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
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
Study Arms (4)
Low dose / continuous VTS
EXPERIMENTALLow dose refers to receiving VTS 5 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
Low dose / speech activated VTS
EXPERIMENTALLow dose refers to receiving VTS 5 times/week for 20 minutes each; VTS during connected speech
High dose / continuous VTS
EXPERIMENTALHigh dose refers to receiving VTS 7 times/week for 20 minutes each; non-task-specific, constant stimulation during non-speech
High dose / speech activated VTS
EXPERIMENTALHigh dose refers to receiving VTS 7 times/week for 20 minutes each; VTS during connected speech
Interventions
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
Eligibility Criteria
You may qualify if:
- years of age or older
- Confirmed diagnosis of adductor or abductor LD for a minimum of 6 months.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2022
First Posted
July 20, 2022
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
May 16, 2025
Record last verified: 2025-05