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Adductor Spasmodic DysphoniaPhase 2/3NCT02528006

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

A Phase 2/3 study testing Type 2 Thyroplasty using Titanium Bridges in people with Adductor Spasmodic Dysphonia, run by Kumamoto University at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Adductor Spasmodic Dysphonia
What is being tested?
Type 2 Thyroplasty using Titanium Bridges
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesJapan
Study dates
27 Jul 2015to 29 Mar 2017
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Dysphagia, laryngeal paralysis, or any structural disorder in the vocal cord
  • Previous surgery for adductor spasmodic dysphonia
  • Local injection of botulinum toxin type A into the intralaryngeal muscles within 6 months before informed consent
  • Serious concomitant diseases
  • Surgery with general anesthesia scheduled during the study period or surgery performed within the past 4 weeks
  • 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
Show all 11Show fewer
  • Psychiatric disorder requiring treatment, or mental or intellectual disability that may affect the conduct of the study
  • A history of alcoholism or drug abuse
  • A history of hypersensitivity to pure titanium
  • Women who are pregnant or planning to become pregnant during the study period
  • Patients deemed ineligible for this study by the investigator for any other reason

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kyoto University Hospital

    Kyoto, 606-8501

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8638

  • Yokohama City University

    Yokohama, Kanagawa, 236-0027

Other trials in Japan

About this study

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.

Read the 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.

Being tested
Type 2 Thyroplasty using Titanium Bridges
Keywords
Spasmodic Dysphonia, Type 2 Thyroplasty, Titanium Bridges, Operation
Medical subject headings
Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type 2 Thyroplasty using Titanium BridgesDevice

Study groups in NCT02528006
Study groupRoleWhat they receive
Titanium BridgesOtherSurgery
Receives: Device: Type 2 Thyroplasty using Titanium Bridges

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VHI-10 scores assessed by Change from baseline in VHI-10 scores at 13 weeks after surgery

    Measured: 13 weeks after surgery

Secondary outcomes (6)

  1. Changes in VHI,VHI-10 scores assessed by Changes in VHI-10 scores before and after surgery

    Measured: 52 weeks after surgery

  2. Changes in VHI,VHI-10 scores assessed by Changes in VHI scores before and after surgery

    Measured: 52 weeks after surgery

  3. Changes in VHI,VHI-10 scores assessed by Changes in VHI subscale scores in the functional (F), (P), and (E)

    Measured: 52 weeks after surgery

  4. Changes in VHI,VHI-10 scores assessed by Changes in phonatory function test results before and after surgery

    Measured: 52 weeks after surgery

  5. Changes in VHI,VHI-10 scores assessed by Changes in acoustic analysis results

    Measured: 52 weeks after surgery

  6. Changes in VHI,VHI-10 scores assessed by Frequency of adverse events and device defects

    Measured: 52 weeks after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study start27 Jul 2015
  3. Primary completion29 Mar 2017
  4. Study completion29 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02528006
Sponsor's protocol ID
001
Other IDs
otostl-0319
Status last verified
Apr 2018
First submitted
10 Aug 2015
Last updated
2 May 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Castelon Konkiewitz E, Trender-Gerhard I, Kamm C, Warner T, Ben-Shlomo Y, Gasser T, Conrad B, Ceballos-Baumann AO. Service-based survey of dystonia in munich. Neuroepidemiology. 2002 Jul-Aug;21(4):202-6. doi: 10.1159/000059525.

    PubMed 12065883

  • Ryuichi Yamazaki. Epidemiological Investigation on Spasmodic Dysphonia: Investigation by Questionnaire. The Japan Journal of Logopedics and Phoniatrics. 2001;42(4):343-347

  • Sulica L. Contemporary management of spasmodic dysphonia. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):543-8. doi: 10.1097/01.moo.0000145959.50513.5e.

    PubMed 15548915

  • Ludlow CL, Adler CH, Berke GS, Bielamowicz SA, Blitzer A, Bressman SB, Hallett M, Jinnah HA, Juergens U, Martin SB, Perlmutter JS, Sapienza C, Singleton A, Tanner CM, Woodson GE. Research priorities in spasmodic dysphonia. Otolaryngol Head Neck Surg. 2008 Oct;139(4):495-505. doi: 10.1016/j.otohns.2008.05.624.

    PubMed 18922334

  • Tisch SH, Brake HM, Law M, Cole IE, Darveniza P. Spasmodic dysphonia: clinical features and effects of botulinum toxin therapy in 169 patients-an Australian experience. J Clin Neurosci. 2003 Jul;10(4):434-8. doi: 10.1016/s0967-5868(03)00020-1.

    PubMed 12852881

  • Blitzer A. Spasmodic dysphonia and botulinum toxin: experience from the largest treatment series. Eur J Neurol. 2010 Jul;17 Suppl 1:28-30. doi: 10.1111/j.1468-1331.2010.03047.x.

    PubMed 20590805

  • Schwartz SR, Cohen SM, Dailey SH, Rosenfeld RM, Deutsch ES, Gillespie MB, Granieri E, Hapner ER, Kimball CE, Krouse HJ, McMurray JS, Medina S, O'Brien K, Ouellette DR, Messinger-Rapport BJ, Stachler RJ, Strode S, Thompson DM, Stemple JC, Willging JP, Cowley T, McCoy S, Bernad PG, Patel MM. Clinical practice guideline: hoarseness (dysphonia). Otolaryngol Head Neck Surg. 2009 Sep;141(3 Suppl 2):S1-S31. doi: 10.1016/j.otohns.2009.06.744.

    PubMed 19729111

  • Tsuji DH, Chrispim FS, Imamura R, Sennes LU, Hachiya A. Impact in vocal quality in partial myectomy and neurectomy endoscopic of thyroarytenoid muscle in patients with adductor spasmodic dysphonia. Braz J Otorhinolaryngol. 2006 Mar-Apr;72(2):261-6. doi: 10.1016/s1808-8694(15)30066-5.

    PubMed 16951863

  • Nakamura K, Muta H, Watanabe Y, Mochizuki R, Yoshida T, Suzuki M. Surgical treatment for adductor spasmodic dysphonia--efficacy of bilateral thyroarytenoid myectomy under microlaryngoscopy. Acta Otolaryngol. 2008;128(12):1348-53. doi: 10.1080/00016480801965019.

    PubMed 18607929

  • Isshiki N, Haji T, Yamamoto Y, Mahieu HF. Thyroplasty for adductor spasmodic dysphonia: further experiences. Laryngoscope. 2001 Apr;111(4 Pt 1):615-21. doi: 10.1097/00005537-200104000-00011.

    PubMed 11359129

  • Isshiki N, Yamamoto I, Fukagai S. Type 2 thyroplasty for spasmodic dysphonia: fixation using a titanium bridge. Acta Otolaryngol. 2004 Apr;124(3):309-12. doi: 10.1080/00016480410016261.

    PubMed 15141760

  • Sanuki T, Isshiki N. Overall evaluation of effectiveness of type II thyroplasty for adductor spasmodic dysphonia. Laryngoscope. 2007 Dec;117(12):2255-9. doi: 10.1097/MLG.0b013e31814684fa.

    PubMed 17921901

  • Sanuki T, Isshiki N. Outcomes of type II thyroplasty for adductor spasmodic dysphonia: analysis of revision and unsatisfactory cases. Acta Otolaryngol. 2009 Nov;129(11):1287-93. doi: 10.3109/00016480802620639.

    PubMed 19863326

  • Isshiki N, Sanuki T. Surgical tips for type II thyroplasty for adductor spasmodic dysphonia: modified technique after reviewing unsatisfactory cases. Acta Otolaryngol. 2010 Feb;130(2):275-80. doi: 10.3109/00016480903036255.

    PubMed 19513892

  • Sanuki T, Yumoto E, Minoda R, Kodama N. Effects of type II thyroplasty on adductor spasmodic dysphonia. Otolaryngol Head Neck Surg. 2010 Apr;142(4):540-6. doi: 10.1016/j.otohns.2009.12.018.

    PubMed 20304275

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Type 2 Thyroplasty using Titanium Bridges in people with Adductor Spasmodic Dysphonia, run by Kumamoto University at 4 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02528006, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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