Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia

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.

Study Overview

• Status: Recruiting
• Conditions: Spasmodic Dysphonia; Laryngeal Dystonia
• Intervention / Treatment: Device: Vibro-tactile stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Cagla Ozkul; Phone Number: 612-624-4370; Email: cozkul@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • University of Minnesota
      • Contact: Cagla Ozkul; Phone Number: 612-624-4370; Email: cozkul@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Will use the device, single group

Device: Vibro-tactile stimulation; Vibro-tactile stimulation is a non-invasive treatment option. As stimulators, we will apply a pair of light-weight encapsulated cylindrical vibrators to both sides of the larynx (voice box). The vibration frequency for VTS will set be to 100Hz and the participant may feel a mild tingling or vibrating sensation during VTS. The participants will be asked to apply for VTS at home over a period of 8 weeks. The participants will be asked to use this device for 3 days in the first week, 4 days in the second week, 5 days in the third week and 6 days in the fourth week. During the last 4 weeks, the participants will apply VTS on self-selected days as needed, not exceeding 6 times a week, to control and improve symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived voice effort	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of voice breaks	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.	8 weeks
The duration of voice break	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.	8 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Juergen Konczak, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2023
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: October 16, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Otorhinolaryngologic Diseases; Dyskinesias; Signs and Symptoms, Respiratory; Laryngeal Diseases; Voice Disorders; Dystonia; Dysphonia; Hoarseness
• Other Study ID Numbers: STUDY00019659

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No