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Essential voice tremor: An unblinded crossover study of botulinum toxin treatment and injection augmentation

Clinical Trial Details

The purpose of this study is to compare treatment with botulinum toxin to treatment with injection augmentation in patients diagnosed with essential voice tremor who are seeking treatment for their voice disorder. 

Botulinum toxin treatment is the injection of botulinum toxin (Botox) into the muscles of the vocal cords through the skin of the neck. This is a standard current treatment for essential voice tremor.

Injection augmentation is the injection of a filler material into the vocal cords through the skin of the neck. This is the current standard treatment for vocal fold paralysis, but the use in essential voice tremor is novel and is the focus of this investigation. 

Periodic injections with Botox is the current standard of care for patients diagnosed with essential voice tremor, but studies show only about 60% of patients benefit substantially enough to continue treatment.  Poor vocal fold closure, a common characteristic of essential voice tremor, is treated in other situations (such as vocal fold paralysis or paresis) with injection augmentation; thus there is reason to think that it may be helpful to patients with essential voice tremor, perhaps even to a greater extent than botulinum toxin.

If you take part in this study, you will be seen for 4 visits (after diagnosis of essential voice tremor). 

#1: Botox Treatment Visit: You will receive Botox treatment (standard of care treatment for EVT).

The following aspects of this visit are for research purposes: There will be no charges for the following:

  • You will be asked to complete two surveys: the 1) Voice Handicap Index-10 (VHI-10), a self-reporting measure of vocal function and limitation, and 2) the Percent of Normal Function Scale (PNF), where you will be asked to rate your voice on a scale of 1-100.
  • You will be seen by your physician to assess the severity of your EVT, and undergo a stroboscopic examination.  The stroboscopic examination is a routine diagnostic examination. It is performed either with no anesthetic or topical (spray) anesthetic, according to your preference.  It involves passing a flexible endoscope through the nose and down the throat to about the level of the back of the tongue.
  • You will have short, non-invasive testing with a speech-language pathologist in the ENT department. The combination of acoustic and aerodynamic testing typically takes approximately 15 minutes.
    • Acoustic testing: You will be asked to produce a series of sounds and standardized sentences into a microphone. This testing helps us analyze the unique characteristics of your voice and allows us to measure changes after treatment.;
    • Aerodynamic testing: You will be asked to produce a series of sounds and standardized sentences into a face mask.  This testing helps us measure how air from the lungs passes between your vocal cords and sets them in motion.
  • You will take the PNF home and will fill it out at home for the duration of the study.

#2: 30-Day Visit: All aspects of this visit are for research purposes: There will be no charges for this visit.

  • You will be asked to complete the VHI-10. 
  • You will be seen by your physician to assess the severity of your EVT, and undergo a stroboscopic examination.
  • You will have short, non-invasive testing with a speech-language pathologist.

#3: 90-Day Injection Augmentation (IA) Visit: All aspects of this visit are for research purposes: There will be no charges for this visit.

  • You will be asked to complete the VHI-10. 
  • You will be seen by your physician to assess the severity of your EVT, and undergo a stroboscopic examination.
  • You will have short, non-invasive testing with a speech-language pathologist.
  • You will undergo Injection Augmentation Treatment.  As is consistent with IA practice, after treatment you will remain at the office for 20 minutes for monitoring.

Visit #4: 120-Day Final Study Visit: All aspects of this visit are for research purposes: There will be no charges for this visit.

  • You will be asked to complete the VHI-10. 
  • You will be seen by your physician to assess the severity of your EVT, and undergo a stroboscopic examination.
  • You will have short, non-invasive testing with a speech-language pathologist.
Key Eligibility: 
  • Men and women 18 years or older
  • Diagnosed with Essential Voice Tremor and are seeking medical treatment to improve voice problems associated with this diagnosis
  • People with laryngeal pathology besides tremor, including but not limited to polyps and other benign lesions, precancerous or cancerous changes, vocal fold paralysis, or other laryngeal disorders of mobility are excluded from this study
  • Detailed eligibility reviewed when you contact the study team

Contact

Katerina Andreadis
Kaa2055@med.cornell.edu
(646) 962-9883

Primary Investigator

Lucian Sulica, M.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1505016165

Status:

Open to Enrollment

Age Group

Adult

Sponsor

Disease

Study Type