Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Minnesota
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Perceived Speech Effort (PSE) at Week 4
Study Overview
Brief Summary
The general aim of the study was to provide evidence for the usability and feasibility of applying vibro-tactile stimulation (VTS) at home as a non-invasive form of neuromodulation to improve speech in people with spasmodic dysphonia (laryngeal dystonia). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options.
Detailed Description
Participants with either adductor or abductor-type of spasmodic dysphonia applied VTS at home for a period of 2 months. During the first four weeks they gradually increased their weekly dosage from 3 to 6 days per week. Each application per day lasted 20 minutes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of spasmodic dysphonia (laryngeal dystonia) for a minimum of 6 months with documented symptom relief after Botox injection.
- •Diagnosis is made by a voice disorder specialist.
Exclusion Criteria
- •Regular intake of benzodiazepines
- •Cognitive impairment: score < 27 on Mini-mental state examination
- •Identifies with a neurological or musculoskeletal impairment affecting speech motor function. These impairments may include a form of: Dyskinesia, Dystonia, 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
Arms & Interventions
Intervention
Laryngeal vibro-tactile stimulation
Intervention: Vibro-tactile stimulation (Device)
Outcomes
Primary Outcomes
Perceived Speech Effort (PSE) at Week 4
Time Frame: Week 4
Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness. Ratings were collected immediately before and after each vibro-tactile stimulation session. The PSE value reported here reflects the group mean at week 4.
Perceived Speech Effort (PSE) at Week 8
Time Frame: Week 8
Perceived Speech Effort was self-rated by participants on a 0-10 scale (0 = no effort, 10 = maximum effort) while reading standardized sentences at habitual pitch and loudness. Ratings were collected immediately before and after each vibro-tactile stimulation session. The PSE value reported here reflects the group mean at week 8.
Voice Quality Change (VQC) at Week 1
Time Frame: Week 1
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. VQC at week 1 represents a baseline measure of symptom severity. It was computed as the mean of the first three sessions of VTS of the study.
Voice Quality Change (VQC) at Week 8
Time Frame: Week 8
Voice Quality Change (VQC) was self-assessed using a 5-point Likert scale (1 = very unnoticeable, 5 = very noticeable; 3 = neutral). Ratings were recorded at the end of each VTS session. The score reflects the overall longitudinal change in symptoms experienced after treatment end. VQC at week 8 was computed as the mean of the last three sessions of the study.
Secondary Outcomes
- Adherence Rate (Feasibility)(Week 1-4)
- Relative Change in Perceived Speech Effort (rPSE) for VTS Application Method(8 weeks)
Investigators
Juergen Konczak
Professor; Director Human Sensorimotor Control Laboratory
University of Minnesota