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Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia

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

Tracking Information
First Submitted Date  ICMJE October 16, 2023
First Posted Date  ICMJE November 1, 2023
Last Update Posted Date November 1, 2023
Actual Study Start Date  ICMJE September 20, 2023
Estimated Primary Completion Date September 20, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2023)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2023)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Usability of Vibro-tactile Stimulation to Treat Spasmodic Dysphonia
Official Title  ICMJE Usability of Laryngeal Vibro-tactile Stimulation as a Non-invasive Treatment for the Voice Disorder Spasmodic Dysphonia
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Usability study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spasmodic Dysphonia
  • Laryngeal Dystonia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Intervention
Will use the device, single group
Intervention: Device: Vibro-tactile stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 29, 2023)		 40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 20, 2024
Estimated Primary Completion Date September 20, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cagla Ozkul 612-624-4370 cozkul@umn.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06111027
Other Study ID Numbers  ICMJE STUDY00019659
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juergen Konczak University of Minnesota
PRS Account University of Minnesota
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP