Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

Spasmodic Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06111027
• Other study ID #: STUDY00019659
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 20, 2023
• Est. completion date: October 20, 2024

Study information

• Verified date: October 2023
• Source: University of Minnesota
• Contact: Cagla Ozkul
• Phone: 612-624-4370
• Email: cozkul[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 20, 2024
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia
• Dystonia
• Hoarseness
• Laryngeal Dystonia
• Spasmodic Dysphonia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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