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Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

NCT06111027 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-20

No results posted yet for this study

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.

Conditions

  • Spasmodic Dysphonia
  • Laryngeal Dystonia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Juergen Konczak · University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-09-20
Completion
2024-10-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06111027 on ClinicalTrials.gov