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

NCT02528006 | Completed Phase 2 DMC

• 2 other identifiers: 001otostl-0319
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

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.

Conditions

Adductor Spasmodic Dysphonia

Keywords

Spasmodic Dysphonia; Type 2 Thyroplasty; Titanium Bridges; Operation

Outcome Measures

Primary Outcomes (1)

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

  13 weeks after surgery

Secondary Outcomes (6)

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

  52 weeks after surgery

• Changes in VHI,VHI-10 scores assessed by Changes in VHI scores before and 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)

  52 weeks after surgery

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

  52 weeks after surgery

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

  52 weeks after surgery

Study Arms (1)

Titanium Bridges

OTHER

Surgery

Device: Type 2 Thyroplasty using Titanium Bridges

Interventions

Type 2 Thyroplasty using Titanium Bridges DEVICE

Titanium Bridges

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kumamoto University: lead
• Hokkaido University Hospital: collaborator
• Yokohama City University Hospital: collaborator
• Kyoto University: collaborator

Study Sites (4)

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8638, Japan

Location

Yokohama City University

Yokohama, Kanagawa, 236-0027, Japan

Location

Kumamoto University Hospital

Kumamoto, 860-8556, Japan

Location

Kyoto University Hospital

Kyoto, 606-8501, Japan

Location

Related Publications (18)

• 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.

  PMID: 12065883 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 15548915 BACKGROUND

• 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.

  PMID: 18922334 BACKGROUND

• 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.

  PMID: 12852881 BACKGROUND

• 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.

  PMID: 20590805 BACKGROUND

• 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.

  PMID: 19729111 BACKGROUND

• 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.

  PMID: 16951863 BACKGROUND

• 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.

  PMID: 18607929 BACKGROUND

• 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.

  PMID: 11359129 BACKGROUND

• 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.

  PMID: 15141760 BACKGROUND

• 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.

  PMID: 17921901 BACKGROUND

• 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.

  PMID: 19863326 BACKGROUND

• 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.

  PMID: 19513892 BACKGROUND

• 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.

  PMID: 20304275 BACKGROUND

• Tetsuji Sanuki, Eiji Yumoto, Narihiro Kodama. Management of Adductor Spasmodic Dysphonia. The Larynx Japan. 2012;24(2):80-83

  BACKGROUND

• Chan SW, Baxter M, Oates J, Yorston A. Long-term results of type II thyroplasty for adductor spasmodic dysphonia. Laryngoscope. 2004 Sep;114(9):1604-8. doi: 10.1097/00005537-200409000-00019.

  PMID: 15475790 BACKGROUND

• Jacobson BH, Johnson A, Grywalski C, et al: The Voice Handicap Index (VHI): development and validation. Am J Speech-Lang Pathol, 1997; 6: 66-70.

  BACKGROUND

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tetsuji Sanuki, MD,PhD

  Department of Otolaryngology,Kumamoto University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 19, 2015
• Study Start: July 27, 2015
• Primary Completion: March 29, 2017
• Study Completion: March 29, 2017
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

JP (4)