Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

• ClinicalTrials.gov Identifier: NCT06111027
• Recruitment Status: Recruiting
• First Posted: November 1, 2023
• Last Update Posted: November 1, 2023
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spasmodic Dysphonia; Laryngeal Dystonia	Device: Vibro-tactile stimulation	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Usability study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
• Actual Study Start Date: September 20, 2023
• Estimated Primary Completion Date: September 20, 2024
• Estimated Study Completion Date: October 20, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Perceived voice effort [ Time Frame: 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 :

1. The number of voice breaks [ Time Frame: 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.
2. The duration of voice break [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Cagla Ozkul; 612-624-4370; cozkul@umn.edu

Locations

United States, Minnesota

University of Minnesota; Recruiting

Minneapolis, Minnesota, United States, 55414

Contact: Cagla Ozkul 612-624-4370 cozkul@umn.edu

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Juergen Konczak; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT06111027
• Other Study ID Numbers: STUDY00019659
• First Posted: November 1, 2023
• Last Update Posted: November 1, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dysphonia; Hoarseness; Dystonia; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory