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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 actua
Sponsor: Kumamoto University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in VHI,VHI-10 scores assessed by Changes in VHI-10 scores before and after surgery [ Time Frame: 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 ]
  • 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 ]
  • Changes in VHI,VHI-10 scores assessed by Changes in phonatory function test results before and after surgery [ Time Frame: 52 weeks after surgery ]
  • Changes in VHI,VHI-10 scores assessed by Changes in acoustic analysis results [ Time Frame: 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 ]


Original Secondary Outcome: Same as current

Information By: Kumamoto University

Dates:
Date Received: August 10, 2015
Date Started: August 2015
Date Completion: September 2017
Last Updated: March 5, 2017
Last Verified: February 2017