Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges
Primary Purpose
Adductor Spasmodic Dysphonia
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Type 2 Thyroplasty using Titanium Bridges
Sponsored by
About this trial
This is an interventional screening trial for Adductor Spasmodic Dysphonia focused on measuring Spasmodic Dysphonia, Type 2 Thyroplasty, Titanium Bridges, Operation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Hokkaido University Hospital
- Yokohama City University
- Kumamoto University Hospital
- Kyoto University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Titanium Bridges
Arm Description
Surgery
Outcomes
Primary Outcome Measures
Change in VHI-10 scores assessed by Change from baseline in VHI-10 scores at 13 weeks after surgery
Secondary Outcome Measures
Changes in VHI,VHI-10 scores assessed by Changes in VHI-10 scores before and after surgery
Changes in VHI,VHI-10 scores assessed by Changes in VHI scores before and after surgery
Changes in VHI,VHI-10 scores assessed by Changes in VHI subscale scores in the functional (F), (P), and (E)
Changes in VHI,VHI-10 scores assessed by Changes in phonatory function test results before and after surgery
Changes in VHI,VHI-10 scores assessed by Changes in acoustic analysis results
Changes in VHI,VHI-10 scores assessed by Frequency of adverse events and device defects
Full Information
NCT ID
NCT02528006
First Posted
August 10, 2015
Last Updated
April 30, 2018
Sponsor
Kumamoto University
Collaborators
Hokkaido University Hospital, Yokohama City University Hospital, Kyoto University
1. Study Identification
Unique Protocol Identification Number
NCT02528006
Brief Title
Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges
Official Title
Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
July 27, 2015 (Actual)
Primary Completion Date
March 29, 2017 (Actual)
Study Completion Date
March 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kumamoto University
Collaborators
Hokkaido University Hospital, Yokohama City University Hospital, Kyoto University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adductor Spasmodic Dysphonia
Keywords
Spasmodic Dysphonia, Type 2 Thyroplasty, Titanium Bridges, Operation
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Titanium Bridges
Arm Type
Other
Arm Description
Surgery
Intervention Type
Device
Intervention Name(s)
Type 2 Thyroplasty using Titanium Bridges
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Changes in VHI,VHI-10 scores assessed by Changes in VHI-10 scores before and after surgery
Time Frame
52 weeks after surgery
Title
Changes in VHI,VHI-10 scores assessed by Changes in VHI scores before and after surgery
Time Frame
52 weeks after surgery
Title
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
Title
Changes in VHI,VHI-10 scores assessed by Changes in phonatory function test results before and after surgery
Time Frame
52 weeks after surgery
Title
Changes in VHI,VHI-10 scores assessed by Changes in acoustic analysis results
Time Frame
52 weeks after surgery
Title
Changes in VHI,VHI-10 scores assessed by Frequency of adverse events and device defects
Time Frame
52 weeks after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetsuji Sanuki, MD,PhD
Organizational Affiliation
Department of Otolaryngology,Kumamoto University
Official's Role
Study Chair
Facility Information:
Facility Name
Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan
Facility Name
Yokohama City University
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
236-0027
Country
Japan
Facility Name
Kumamoto University Hospital
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8501
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
12065883
Citation
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.
Results Reference
background
Citation
Ryuichi Yamazaki. Epidemiological Investigation on Spasmodic Dysphonia: Investigation by Questionnaire. The Japan Journal of Logopedics and Phoniatrics. 2001;42(4):343-347
Results Reference
background
PubMed Identifier
15548915
Citation
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.
Results Reference
background
PubMed Identifier
18922334
Citation
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.
Results Reference
background
PubMed Identifier
12852881
Citation
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.
Results Reference
background
PubMed Identifier
20590805
Citation
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.
Results Reference
background
PubMed Identifier
19729111
Citation
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.
Results Reference
background
PubMed Identifier
16951863
Citation
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.
Results Reference
background
PubMed Identifier
18607929
Citation
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.
Results Reference
background
PubMed Identifier
11359129
Citation
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.
Results Reference
background
PubMed Identifier
15141760
Citation
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.
Results Reference
background
PubMed Identifier
17921901
Citation
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.
Results Reference
background
PubMed Identifier
19863326
Citation
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.
Results Reference
background
PubMed Identifier
19513892
Citation
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.
Results Reference
background
PubMed Identifier
20304275
Citation
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.
Results Reference
background
Citation
Tetsuji Sanuki, Eiji Yumoto, Narihiro Kodama. Management of Adductor Spasmodic Dysphonia. The Larynx Japan. 2012;24(2):80-83
Results Reference
background
PubMed Identifier
15475790
Citation
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.
Results Reference
background
Citation
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.
Results Reference
background
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Treatment for Adductor Spasmodic Dysphonia by Type 2 Thyroplasty Using Titanium Bridges
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