Study Summary
This trial is studying DBS to see if it can help people with spasmodic dysphonia.
Eligible Conditions
- Hoarseness
- Spasmodic Dysphonia
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 6 months
6 months
Patient Voice-Related Quality of Life
Patient Voice-Related Quality of Life as assessed by the Voice-Related Quality of Life questionnaire.
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
2 Treatment Groups
DBS On
1 of 2
DBS Off
1 of 2
Experimental Treatment
Non-Treatment Group
16 Total Participants · 2 Treatment Groups
Primary Treatment: DBS ON · Has Placebo Group · Phase 2
DBS On
Device
Experimental Group · 1 Intervention: DBS ON · Intervention Types: DeviceDBS Off
Device
ShamComparator Group · 1 Intervention: DBS OFF · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,315 Previous Clinical Trials
1,267,893 Total Patients Enrolled
1 Trials studying Hoarseness
6 Patients Enrolled for Hoarseness
Christopher R Honey, MDPrincipal InvestigatorUniversity of British Columbia
Eligibility Criteria
Age 18+ · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The diagnosis of spasmodic dysphonia is evaluated by two centres - one team in Vancouver and the other team in Indiana.
The patient is receiving Botox treatments to help improve their appearance
About The Reviewer
Michael Gill - B. Sc.
First Published: October 6th, 2021
Last Reviewed: November 18th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Bielamowicz, Steven, Sheila V Stager, Andrea Badillo, and Alexis Godlewski. 2002. “Unilateral Versus Bilateral Injections of Botulinum Toxin in Patients with Adductor Spasmodic Dysphonia”. Journal of Voice. Elsevier BV. doi:10.1016/s0892-1997(02)00080-2.
- White, Laura J., Adam M. Klein, Edie R. Hapner, John M. Delgaudio, John J. Hanfelt, Hyder A. Jinnah, and Michael M. Johns III. 2011. “Coprevalence of Tremor with Spasmodic Dysphonia”. The Laryngoscope. Wiley. doi:10.1002/lary.21872.
- Zwirner, Petra, Thomas Murry, Michael Swenson, and Gayle E. Woodson. 1992. “Effects of Botulinum Toxin Therapy in Patients with Adductor Spasmodic Dysphonia: Acoustic, Aerodynamic, and Videoendoscopic Findings”. The Laryngoscope. Wiley. doi:10.1288/00005537-199204000-00006.
- Jankovic, J, K Schwartz, and D T Donovan. 1990. “Botulinum Toxin Treatment of Cranial-cervical Dystonia, Spasmodic Dysphonia, Other Focal Dystonias and Hemifacial Spasm.”. Journal of Neurology, Neurosurgery & Psychiatry. BMJ. doi:10.1136/jnnp.53.8.633.
- Patel, Rita R., Shaheen N. Awan, Julie Barkmeier-Kraemer, Mark Courey, Dimitar Deliyski, Tanya Eadie, Diane Paul, Jan G. Švec, and Robert Hillman. 2018. “Recommended Protocols for Instrumental Assessment of Voice: American Speech-language-hearing Association Expert Panel to Develop a Protocol for Instrumental Assessment of Vocal Function”. American Journal of Speech-language Pathology. American Speech Language Hearing Association. doi:10.1044/2018_ajslp-17-0009.
- Roy, Nelson, Shannon C. Mauszycki, Ray M. Merrill, Manon Gouse, and Marshall E. Smith. 2007. “Toward Improved Differential Diagnosis of Adductor Spasmodic Dysphonia and Muscle Tension Dysphonia”. Folia Phoniatrica Et Logopaedica. S. Karger AG. doi:10.1159/000098341.
- Yiu, Yin, Carolyn R. Baylor, Alyssa M. Bamer, Sandeep Shelly, Adam M. Klein, C. Gaelyn Garrett, and Michael J. Pitman. 2020. “Validation of the Communicative Participation Item Bank as an Outcome Measure for Spasmodic Dysphonia”. The Laryngoscope. Wiley. doi:10.1002/lary.28897.
- Bürgel, U., B. Mädler, C. Honey, A. Thron, J. Gilsbach, and V. Coenen. 2009. “Fiber Tracking with Distinct Software Tools Results in a Clear Diversity in Anatomical Fiber Tract Portrayal”. Central European Neurosurgery. Georg Thieme Verlag KG. doi:10.1055/s-0028-1087212.
- Parker, Lindsey A., Melda Kunduk, Daniel S. Fink, and Andrew McWhorter. 2019. “Reliability of High-speed Videoendoscopic Ratings of Essential Voice Tremor and Adductor Spasmodic Dysphonia”. Journal of Voice. Elsevier BV. doi:10.1016/j.jvoice.2017.10.009.
- Honey, Christopher R, Marie T Krüger, Timóteo Almeida, Linda A Rammage, Mandeep S Tamber, Murray D Morrison, Anujan Poologaindran, and Amanda Hu. 2021. “Thalamic Deep Brain Stimulation for Spasmodic Dysphonia”. Neurosurgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1093/neuros/nyab095.
- Poburka, Bruce J., Rita R. Patel, and Diane M. Bless. 2017. “Voice-vibratory Assessment with Laryngeal Imaging (VALI) Form: Reliability of Rating Stroboscopy and High-speed Videoendoscopy”. Journal of Voice. Elsevier BV. doi:10.1016/j.jvoice.2016.12.003.
- Simonyan, Kristina, Fernanda Tovar-Moll, John Ostuni, Mark Hallett, Victor F. Kalasinsky, Michael R. Lewin-Smith, Elisabeth J. Rushing, Alexander O. Vortmeyer, and Christy L. Ludlow. 2007. “Focal White Matter Changes in Spasmodic Dysphonia: A Combined Diffusion Tensor Imaging and Neuropathological Study”. Brain. Oxford University Press (OUP). doi:10.1093/brain/awm303.
- Coenen, V. A., C. Jenkner, C. R. Honey, and B. Ma dler. 2016. “Electrophysiologic Validation of Diffusion Tensor Imaging Tractography During Deep Brain Stimulation Surgery”. American Journal of Neuroradiology. American Society of Neuroradiology (ASNR). doi:10.3174/ajnr.a4753.
- Patel, Rita R., Li Liu, Nikolaos Galatsanos, and Diane M. Bless. 2011. “Differential Vibratory Characteristics of Adductor Spasmodic Dysphonia and Muscle Tension Dysphonia on High-speed Digital Imaging”. Annals of Otology, Rhinology & Laryngology. SAGE Publications. doi:10.1177/000348941112000104.
- Roy N, Mauszycki SC, Merrill RM, Gouse M, Smith ME. Toward improved differential diagnosis of adductor spasmodic dysphonia and muscle tension dysphonia. Folia Phoniatr Logop. 2007;59(2):83-90. doi: 10.1159/000098341.
- Patel RR, Liu L, Galatsanos N, Bless DM. Differential vibratory characteristics of adductor spasmodic dysphonia and muscle tension dysphonia on high-speed digital imaging. Ann Otol Rhinol Laryngol. 2011 Jan;120(1):21-32. doi: 10.1177/000348941112000104.
- Coenen VA, Jenkner C, Honey CR, Madler B. Electrophysiologic Validation of Diffusion Tensor Imaging Tractography during Deep Brain Stimulation Surgery. AJNR Am J Neuroradiol. 2016 Aug;37(8):1470-8. doi: 10.3174/ajnr.A4753. Epub 2016 Mar 31.
- Burgel U, Madler B, Honey CR, Thron A, Gilsbach J, Coenen VA. Fiber tracking with distinct software tools results in a clear diversity in anatomical fiber tract portrayal. Cent Eur Neurosurg. 2009 Feb;70(1):27-35. doi: 10.1055/s-0028-1087212. Epub 2009 Feb 3.
- Patel RR, Awan SN, Barkmeier-Kraemer J, Courey M, Deliyski D, Eadie T, Paul D, Svec JG, Hillman R. Recommended Protocols for Instrumental Assessment of Voice: American Speech-Language-Hearing Association Expert Panel to Develop a Protocol for Instrumental Assessment of Vocal Function. Am J Speech Lang Pathol. 2018 Aug 6;27(3):887-905. doi: 10.1044/2018_AJSLP-17-0009.
- Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
- Simonyan K, Tovar-Moll F, Ostuni J, Hallett M, Kalasinsky VF, Lewin-Smith MR, Rushing EJ, Vortmeyer AO, Ludlow CL. Focal white matter changes in spasmodic dysphonia: a combined diffusion tensor imaging and neuropathological study. Brain. 2008 Feb;131(Pt 2):447-59. doi: 10.1093/brain/awm303. Epub 2007 Dec 14.
- Christopher Honey 2023. "A Phase 2 Trial of Deep Brain Stimulation for Spasmodic Dysphonia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04938154.
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