Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges

April 30, 2018 updated by: Kumamoto University
For adductor spasmodic dysphonia, there is a need for establishing a new therapy under the present circumstance where no standard therapy has been established yet and existing therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty using titanium bridges will expand the therapeutic options available for adductor spasmodic dysphonia and establishment of a standard therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spasmodic dysphonia is a type of functional dysphonia not associated with any organic abnormality or palsy of the larynx. The speech disorder in this disease is caused by involuntary and intermittent spasms of the intralaryngeal muscles (Castelon, 2002).

There is no curative treatment for this disease. Conservative therapies include voice training (voice therapy) and muscle relaxant medication to ease the tension in the larynx during speech, although there is not much evidence to support the effectiveness of either. An internationally employed therapy is local injection of botulinum toxin A into the intralaryngeal muscles to suppress involuntary movements of the vocal cords. The injection can be administered percutaneously from the anterior neck within a short time, and a number of reports have indicated a greater than 90% efficacy of this treatment (Tisch 2003, Blitzer 2010). However, this local injection therapy is effective only for a limited period of 3 to 4 months, and periodic injections have to be continued throughout life for maintaining relief from the symptoms under the present circumstances.

Type 2 thyroplasty is an operative procedure in which the thyroid cartilage is incised at the midline, and the incised gap is opened and fixed with the thyroarytenoid muscles attached on both sides, so that the vocal cords do not shut too tightly during speech even with strong adduction of the glottis, as the symptoms of adductor spasmodic dysphonia are caused by excessive closure of the glottis due to strong involuntary and intermittent adduction of the intralaryngeal muscles (Isshiki 2001).

In 2002, the titanium bridge made of biocompatible pure titanium was developed in Japan for exclusive use in type 2 thyroplasty (Isshiki 2004). When the titanium bridge was used in actual cases, the symptoms disappeared without recurrence after the operation (Sanuki 2007, Sanuki 2009, Isshiki & Sanuki 2009, Sanuki 2010).

There is a need for establishing a new therapy under the present circumstance where no standard therapy has been established yet and existing therapies fail to provide permanent effect. Evaluation of the efficacy of type 2 thyroplasty using titanium bridges will expand the therapeutic options available for adductor spasmodic dysphonia and establishment of a standard therapy.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital
      • Kyoto, Japan, 606-8501
        • Kyoto University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8638
        • Hokkaido University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0027
        • Yokohama City University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Diagnosis of adductor spasmodic dysphonia by a board certified otorhinolaryngologist certified by the Oto-Rhino-Laryngological Society of Japan, Inc.
  2. At least 1 year experience of subjective or objective labored speech production, or pauses on certain sounds, due to adductor spasmodic dysphonia
  3. A total score of 20 or more on the Voice Handicap Index-10 (VHI-10)
  4. Non-responders to voice therapy performed before informed consent
  5. 18 through 80 years of age inclusive at the time of informed consent
  6. Written informed consent to participate in this study, provided by patients or their legally acceptable representatives

Exclusion Criteria:

  1. Dysphagia, laryngeal paralysis, or any structural disorder in the vocal cord
  2. Previous surgery for adductor spasmodic dysphonia
  3. Local injection of botulinum toxin type A into the intralaryngeal muscles within 6 months before informed consent
  4. Serious concomitant diseases
  5. Surgery with general anesthesia scheduled during the study period or surgery performed within the past 4 weeks
  6. Participation in any other study using any other intervention within 12 weeks before informed consent, or planned participation in such a study during the study period after enrollment in this study
  7. Psychiatric disorder requiring treatment, or mental or intellectual disability that may affect the conduct of the study
  8. A history of alcoholism or drug abuse
  9. A history of hypersensitivity to pure titanium
  10. Women who are pregnant or planning to become pregnant during the study period
  11. Patients deemed ineligible for this study by the investigator for any other reason

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Titanium Bridges
Surgery
Device: Type 2 Thyroplasty using Titanium Bridges

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in VHI-10 scores assessed by Change from baseline in VHI-10 scores at 13 weeks after surgery
Time Frame: 13 weeks after surgery
13 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in VHI,VHI-10 scores assessed by Changes in VHI-10 scores before and after surgery
Time Frame: 52 weeks after surgery
52 weeks after surgery
Changes in VHI,VHI-10 scores assessed by Changes in VHI scores before and after surgery
Time Frame: 52 weeks after surgery
52 weeks after surgery
Changes in VHI,VHI-10 scores assessed by Changes in VHI subscale scores in the functional (F), (P), and (E)
Time Frame: 52 weeks after surgery
52 weeks after surgery
Changes in VHI,VHI-10 scores assessed by Changes in phonatory function test results before and after surgery
Time Frame: 52 weeks after surgery
52 weeks after surgery
Changes in VHI,VHI-10 scores assessed by Changes in acoustic analysis results
Time Frame: 52 weeks after surgery
52 weeks after surgery
Changes in VHI,VHI-10 scores assessed by Frequency of adverse events and device defects
Time Frame: 52 weeks after surgery
52 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kumamoto University

Collaborators

Kyoto University
Hokkaido University Hospital
Yokohama City University Hospital

Investigators

  • Study Chair: Tetsuji Sanuki, MD,PhD, Department of Otolaryngology,Kumamoto University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2015

Primary Completion (Actual)

March 29, 2017

Study Completion (Actual)

March 29, 2017

Study Registration Dates

First Submitted

August 10, 2015

First Submitted That Met QC Criteria

August 17, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

May 2, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)
  • otostl-0319 (Other Identifier: UMIN-CTR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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