Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation
Condition: Essential Tremor
MeSH terms: Tremor; Essential Tremor
Study type: Interventional

Summary: 
      Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor
      (EVT), but results are not universally beneficial to all patients. Inconsistent results are
      noted in the literature and are consistent with the PI's clinical experience. Injection
      augmentation, a well-established treatment for glottic insufficiency, which is a prominent
      factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied. By
      treating patients at separate times with botulinum toxin and injection augmentation in an
      unblinded prospective crossover treatment study, we can assess functional outcomes of these
      two treatments with the population of patients with Essential Voice Tremor (EVT).
    

Detailed description: 
      The purpose of this study is to compare treatment with botulinum toxin to treatment with
      injection augmentation in patients diagnosed with essential voice tremor.

      Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal
      cords through the skin of the neck. This is identical to the injections you may have received
      in the past for your disorder.

      Injection augmentation is the injection of a filler material into the vocal cords through the
      skin of the neck, guided by the view from a flexible laryngoscope inserted through the
      nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to
      examine your vocal cords in the past. It is the routine diagnostic evaluation technique of
      voice disorders.

      Periodic injections with botulinum toxin (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.
    

Intervention name(s): RenuGel; Botulinum Toxin
Intervention type(s): Drug; Drug
Intervention description(s): Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.; Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Other intervention name(s): generic: Carboxymethylcellulose; Botox
Intervention MeSH terms: Carboxymethylcellulose Sodium; Botulinum Toxins
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: botulinum toxin; injection augmentation; essential voice tremor