Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

Phase 1

Completed

• Conditions: Spasmodic Dysphonia; Laryngeal Dystonia
• Interventions: Device: Vibro-tactile stimulation

• Registration Number: NCT06111027
• Lead Sponsor: University of Minnesota

Brief Summary

The general aim of the study is to provide evidence for 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 (SD). This work addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with very limited treatment options. Successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving voice symptoms in SD.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Study First Submitted: 2023-10-16
• Study First Submitted QC: 2023-10-29
• Study First Posted: 2023-11-01
• Primary Completion: 2024-09-20
• Study Completion: 2024-10-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Vibro-tactile stimulation	Will use the device, single group

Primary Outcome Measures

Name	Time	Method
Perceived voice effort	8 weeks	Participants will rate their perceived effort level of vocalization on an ordinal scale of 0 to 10 (0 being with no effort and 10 being with maximal effort). The recordings will provide subjective impression of treatment.

Secondary Outcome Measures

Name	Time	Method
The duration of voice break	8 weeks	Prior to study begin, participants will receive a manual with instructions about the remote audio recording procedure. During pre- and post-application assessment, participants will record their voices using a voice recording application on their smartphone or digital tablet. The recordings will provide objective data on the duration of voice breaks.
The number of voice breaks	8 weeks	Prior to study begin, participants will receive a manual with instructions about the remote audio recording procedure. During pre- and post-application assessment, participants will record their voices using a voice recording application on their smartphone or digital tablet. The recordings will provide objective data on the number of voice breaks.

Trial Locations

Locations (1)

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