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Laryngeal Vibration for Spasmodic Dysphonia (SD-VTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03746509
Recruitment Status : Recruiting
First Posted : November 19, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:
The general aim of the research is to provide scientific evidence that VTS represents a non-invasive form of neuromodulation that can induce measurable improvements in the speech of SD patients. This research addresses a clinical need to develop alternative or auxiliary treatments for a rare voice disorder with limited treatment options. A successful completion of the proposed work will be an important step in advancing laryngeal VTS as a therapeutic intervention for improving the voice symptoms in SD. Specifically, the scientific yield by achieving the specific aims is threefold: First, it will elucidate the unknown neurophysiological mechanism behind laryngeal VTS by documenting the neural changes associated with VTS. Second, it will establish that VTS can improve voice quality in SD. Third, by documenting that laryngeal VTS yields long-term benefits on voice quality in SD patients, it would provide a solid basis for a clinical trial that needs to address open questions on optimal dosage and duration of VTS-based voice therapy, the magnitude of the therapeutic effect across adductor and abductor SD and its longterm efficacy.

Condition or disease Intervention/treatment Phase
Spasmodic Dysphonia Device: Laryngeal Vibration (Treatment) Device: Laryngeal Vibration (Comparator) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Laryngeal Vibration as a Non-invasive Treatment for Spasmodic Dysphonia
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Low-High Treatment
Participants in the low-high treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency every second day of the week (high intensity) for a duration of 4 weeks.
Device: Laryngeal Vibration (Treatment)
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.

Experimental: High-Low Treatment
Participants in the high-low treatment group will receive Laryngeal Vibration (Treatment) at 100Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 100Hz frequency once a week for a duration of 4 weeks (low intensity).
Device: Laryngeal Vibration (Treatment)
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.

Active Comparator: Low-High Comparator
Participants in the low-high comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency once a week for a duration of 4 weeks (low intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency every second day of the week (high intensity) for a duration of 4 weeks.
Device: Laryngeal Vibration (Comparator)
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.

Active Comparator: High-Low Comparator
Participants in the high-low comparator group will receive Laryngeal Vibration (Comparator) at 5Hz frequency every second day of the week for a duration of 4 weeks (high intensity). Then they will switch and receive laryngeal vibration at 5Hz frequency once a week for a duration of 4 weeks (low intensity).
Device: Laryngeal Vibration (Comparator)
The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.




Primary Outcome Measures :
  1. Voice assessment 1 (baseline) [ Time Frame: Testing performed in lab at Week 1 ]
    To assess voice quality, participants will perform a series of voice production tasks in lab. Voice production before, during, and after the vibration will be recorded via a microphone for subsequent acoustic analysis on voice quality by speech analysis experts.

  2. Voice assessment to measure change from baseline [ Time Frame: Testing performed in lab at Week 6 ]
    To assess voice quality, participants will perform a series of voice production tasks in lab. Voice production before, during, and after the vibration will be recorded via a microphone for subsequent acoustic analysis on voice quality by speech analysis experts.

  3. Final voice assessment to measure change from baseline [ Time Frame: Testing performed in lab at Week 11 ]
    To assess voice quality, participants will perform a series of voice production tasks in lab. Voice production before, during, and after the vibration will be recorded via a microphone for subsequent acoustic analysis on voice quality by speech analysis experts.


Secondary Outcome Measures :
  1. Measuring of cortical activity using electroencephalography (EEG) (baseline) [ Time Frame: Testing performed in lab at Week 1 ]
    Cortical activity before, during, and after the vibration will be recorded via a a 64-channel EEG system at a sampling frequency of 512 Hz.

  2. Measuring of cortical activity using electroencephalography (EEG) to measure change from baseline [ Time Frame: Testing performed in lab at Week 6 ]
    Cortical activity before, during, and after the vibration will be recorded via a a 64-channel EEG system at a sampling frequency of 512 Hz.

  3. Final measuring of cortical activity using electroencephalography (EEG) to measure change from baseline [ Time Frame: Testing performed in lab at Week 11 ]
    Cortical activity before, during, and after the vibration will be recorded via a a 64-channel EEG system at a sampling frequency of 512 Hz.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diagnosis of adductor SD for a minimum of 6 months with documented symptom relief after botox injection

Exclusion Criteria:

  • abductor SD
  • patients with other voice disorders such as muscle tension dysphonia that share some of the symptomology with SD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746509


Contacts
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Contact: Juergen Konczak, PhD 612-624-4370 jkonczak@umn.edu
Contact: Arash Mahnan, M.S. 612-625-3313 amahnan@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Arash Mahnan, M.S.    612-625-3313    amahnan@umn.edu   
Contact: Naveen Elangovan, Ph.D.    612-625-3313    naveen@umn.edu   
Principal Investigator: Juergen Konczak, PhD         
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Juergen Konczak, PhD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03746509    
Other Study ID Numbers: STUDY00004618
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Dystonia
Spasmodic dysphonia
Laryngeal dystonia
Additional relevant MeSH terms:
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Dysphonia
Hoarseness
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Respiration Disorders
Signs and Symptoms, Respiratory